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Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:
Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00734747
Study type Interventional
Source MediGus Ltd
Contact
Status Completed
Phase Phase 3
Start date May 2008
Completion date July 2015
View Details
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