NCT00734747

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Aviel Roy-Shapira, M.D. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DEVICE	Medigus SRS endoscopic stapling system	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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-05-01
• Completion: 2015-07-01
• First posted: 2008-08-14
• Last updated: 2016-02-02
• Results posted: 2015-08-14

Locations

6 sites across 5 countries: United States, Austria, Germany, India, Italy