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

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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.

Key facts

Study ID

NCT00734747

Run by

Aviel Roy-Shapira, M.D.

People needed

72

Starts

2008-05-01

Expected to finish

2015-07-01

Last updated by the study team

2016-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 proton pump inhibitors (PPIs) for at least 6 months, with significant relief of symptoms (i.e., difference in GERD Health Related Quality of Life (GERD HRQL) scores on and off PPI > =6).
• GERD-HRQL ≥20 off of PPI's

You may not qualify if…

• 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

Where it is running

• UC San Diego — San Diego, California, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Akh Vienna City General Hospital — Vienna, Austria
• Med.Klinik Universitatsmedizin — Mainz, Germany
• Deenanath Mangeshkar Hospital and Medical Research Center — Pune, India
• Medical University of Milan - San Donato Hospital — Milan, Italy

Full record on ClinicalTrials.gov

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