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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: endoscopic full thickness plication

• Registration Number: NCT01798212
• Lead Sponsor: Krankenhaus Barmherzige Schwestern Linz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Study Start: 2013-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
full thickness gastroplication	endoscopic full thickness plication	-

Primary Outcome Measures

Name	Time	Method
Quality of Life using the Gastrointestinal Quality of Life Index	change from baseline in Quality of Life at 3 months, one year and three years after the intervation

Secondary Outcome Measures

Name	Time	Method
lower esophageal sphincter pressure using oesophageal manometry	change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion
DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment	change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion

Trial Locations

Locations (2)

Krankenhaus Zell am See; 🇦🇹 Zell am See, Austria

Krankenhaus Barmherzige Schwestern; 🇦🇹 Linz, Austria