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Completed

NCT Number: NCT01136980

Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

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About this study

Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).

Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.

Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years
  • Dependent upon daily PPIs for > 6 months
  • Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent.

Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.

  • Abnormal ambulatory pH study off PPI therapy for 7 days.
  • Normal or near normal esophageal motility (by manometry)
  • Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm
  • Patient willing to cooperate with post-operative dietary recommendations and assessment tests
  • Signed informed consent

Exclusion criteria

  • BMI > 35
  • Hiatal hernia > 2 cm
  • Esophagitis Los Angeles grade C or D
  • Esophageal ulcer
  • Esophageal stricture
  • Esophageal motility disorder
  • Pregnancy or plans for pregnancy in the next 12 months (in females)
  • Immunosuppression
  • ASA > 2
  • Portal hypertension and/or varices
  • History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Active gastro-duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
  • Coagulation disorders
  • Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.

Treatment and study plan

TIF Transoral Fundoplication

Device

A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)

Other names: TIF

Sham placebo procedure

Other

The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.

Other names: Sham Procedure

Primary outcomes

  1. Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,

    Time frame: 6 month follow up

    Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.

Secondary outcomes

  1. Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score

    Time frame: 6 months post procedure

    DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is < 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are:

    • total number of episodes of reflux, - reflux is undesirable, therefore lower numbers are better, higher numbers are worse. Ideally there would be zero reflux episodes.
    • % total time esophageal pH < 4, upright position and supine position, respectively - pH < 4 is undesirable, therefor lower percentages are better
    • number of episodes longer than 5 minutes, - lower is better
    • maximal reflux duration, (reflux is undesirable - lower is better
    • total percentage of time with pH below 4 - below 4 is undesirable - lower is better

    The composite score can be obtained by adding the scores calculated for each of the six components.

Sponsors and collaborators

Lead sponsor

EndoGastric Solutions

Industry

Registry information

Official study title

A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls

Acronym: RESPECT

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Jun 4, 2010
Registry last updated
Dec 3, 2021

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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