Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

November 15, 2017

Primary Completion Date

August 30, 2019

Study Completion Date

December 30, 2019

Conditions
Gastro Esophageal Reflux Disease
Interventions
DEVICE

GERD-X

Endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device.

Trial Locations (1)

500082

Asian institute of Gastroenterology, Hyderabad

All Listed Sponsors
lead

Asian Institute of Gastroenterology, India

OTHER

NCT03322553 - Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD: | Biotech Hunter | Biotech Hunter