Overview

This trial is active, not recruiting.

Condition gastroesophageal reflux disease (gerd)
Treatment medigus srs endoscopic stapling system
Phase phase 3
Sponsor Aviel Roy-Shapira, M.D.
Start date May 2008
End date May 2011
Trial size 72 participants
Trial identifier NCT00734747, DCLP09002

Summary

The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD.

The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed.

The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Endoluminal fundoplication for the treatment of GERD
medigus srs endoscopic stapling system endoluminal treatment of GERD
The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location.

Primary Outcomes

Measure
Improved GERD Health Related Quality of life (GERD-HRQL - Velanovitch) scores by 50% or more
time frame: Six months
Procedure-related adverse events
time frame: 30 days

Secondary Outcomes

Measure
Reduction of acid exposure (%time pH<4) on off PPI ambulatory 24h acid exposure test
time frame: 6 months
Reduction of Proton Pump inhibitor use, as reported by subject
time frame: 6 months
A grade I or II gastroesophageal flap valve according to the Hill classification (by endoscopy)
time frame: Six months
In subjects with hiatal hernia, maintenance of reduction
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - History of GERD related symptoms for at least 2 years. - Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test. - History of daily intake of PPIs for at least 6 months, with significant relief of symptoms (i.e., difference in GERD HRQL scores on and off PPI > =6). - GERD-HRQL ≥20 off of PPI's Exclusion Criteria: - Hiatal hernia > 3 cm or a paraesophageal hernia - Barrett's esophagus or grade IV esophagitis - Esophageal stricture, ring or web causing symptoms of dysphagia - Grade I Flap valve according Hill's classification - History of co-morbidity

Additional Information

Official title Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by MediGus Ltd.