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Completed

NCT Number: NCT01798212

Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD.

The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus Barmherzige Schwestern, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Written informed consent; ≥ 18 years of age;

GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria:

  • Total Number of Reflux Events ≥ 73/24h;
  • DeMeester Score ≥ 14.7;
  • Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks.

Exclusion criteria

Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction;

≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia >2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification >II

Treatment and study plan

endoscopic full thickness plication

Procedure

Other names: GERDx™

Primary outcomes

  1. Quality of Life using the Gastrointestinal Quality of Life Index

    Time frame: change from baseline in Quality of Life at 3 months, one year and three years after the intervation

Secondary outcomes

  1. lower esophageal sphincter pressure using oesophageal manometry

    Time frame: change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion

  2. DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment

    Time frame: change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Registry information

Official study title

A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2013
Registry last updated
Mar 1, 2017

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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