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

Aviel Roy-Shapira, M.D.

Status and phase

Completed

Phase 3

Conditions

Gastroesophageal Reflux Disease (GERD)

Treatments

Device: Medigus SRS endoscopic stapling system

Study type

Interventional

Funder types

Industry

Identifiers

NCT00734747

DCLP09002

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

Exclusion criteria