CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
Medigus SRS endoscopic stapling systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00734747
NCT00734747Phase 3Completed
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Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

Aviel Roy-Shapira, M.D.·interventional·Posted Aug 14, 2008·Updated Feb 2, 2016

In Brief

A Phase 3 clinical trial evaluating Medigus SRS endoscopic stapling system for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 72 participants across 6 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease (GERD)
CountriesAustria, Germany, India, Italy, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2008
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2011
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.9 years ago

Interventions

Medigus SRS endoscopic stapling systemdevice

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.