Pier Alberto Testoni
Milan, 20132, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT03669874
Endoscopic Fundoplication With MUSE System
This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:
* Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:
* effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores * effect on the use and dosage of proton pump inhibitors (PPI) * feasibility and safety of the endoluminal fundoplication procedure * Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.
The study design includes the following phases:
*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
* 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * Yearly clinical follow-up (up to 6 years):
PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
- Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
- Indication to surgical fundoplication
- Patients available for a long-term follow-up
Exclusion criteria
- Hiatal hernia ≥ 3 cm
- Major esophageal motility disorder
- Esophageal stenosis
- Malignant neoplasia (except minor superficial skin neoplasm)
- Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
- Previous cardiac, thoracic or upper GI surgery
- BMI >40
- Pregnancy or breast feeding
Treatment and study plan
Endoscopic fundoplication
DeviceEndoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.
The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.
Primary outcomes
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 6 months
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 12 months
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 24 months
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 3 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 4 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 5 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 6 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 6 months
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 12 months
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 24 months
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 3 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 4 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 5 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 6 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 6 months
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 12 months
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 24 months
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 3 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 4 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 5 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
-
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 6 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Secondary outcomes
-
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Time frame: change from baseline hiatal hernia size at 6 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
-
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Time frame: change from baseline hiatal hernia size at 12 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
-
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Time frame: change from baseline Hill's grade at 6 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
-
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Time frame: change from baseline Hill's grade at 12 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
-
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Time frame: change from baseline Jobe's lenght at 6 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
-
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Time frame: change from baseline Jobe's lenght at 12 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
-
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Time frame: change from baseline esophagitis' grade at 6 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
-
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Time frame: change from baseline esophagitis' grade at 12 months
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
-
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
Time frame: change from baseline DeMeester score at 6 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
-
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
Time frame: change from baseline DeMeester score at 12 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
-
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
Time frame: change from baseline AET at 6 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
Time frame: change from baseline AET at 12 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
Time frame: change from baseline longest reflux episode at 6 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
Time frame: change from baseline longest reflux episode at 12 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
Time frame: change from baseline number of refluxes greater than 5 minutes at 6 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
Time frame: change from baseline number of refluxes greater than 5 minutes at 12 months
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
Time frame: change from baseline number of total refluxes at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
Time frame: change from baseline number of total refluxes at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
Time frame: change from baseline number of acid refluxes at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
Time frame: change from baseline number of acid refluxes at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
Time frame: change from baseline number of weakly acid refluxes at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
Time frame: change from baseline number of weakly acid refluxes at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
Time frame: change from baseline number of not acid refluxes at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
Time frame: change from baseline number of not acid refluxes at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
Time frame: change from baseline number of proximal refluxes at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
Time frame: change from baseline number of proximal refluxes at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
Time frame: change from baseline MNBI at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
Time frame: change from baseline MNBI at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
Time frame: change from baseline PSPW at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
Time frame: change from baseline PSPW at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
Time frame: change from baseline BCT at 6 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
Time frame: change from baseline BCT at 12 months
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
-
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
Time frame: change from baseline LES basal pressure at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
Time frame: change from baseline LES basal pressure at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
Time frame: change from baseline LES lenght at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
Time frame: change from baseline LES lenght at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
Time frame: change from baseline LES IRP at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
Time frame: change from baseline LES IRP at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
Time frame: change from baseline DCI at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
Time frame: change from baseline DCI at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves
Time frame: change from baseline rate of peristaltic waves at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves
Time frame: change from baseline rate of peristaltic waves at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves
Time frame: change from baseline rate of weak waves at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves
Time frame: change from baseline rate of weak waves at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves
Time frame: change from baseline rate of fragmented waves at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves
Time frame: change from baseline rate of fragmented waves at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves
Time frame: change from baseline rate of failed waves at 6 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
-
To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves
Time frame: change from baseline rate of failed waves at 12 months
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
IRCCS San Raffaele
Other
Registry information
Official study title
Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
Important dates
- Study start
- 2015
- Primary completion
- 2021
- Study completion
- 2026
- First posted
- Sep 13, 2018
- Registry last updated
- Dec 11, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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