70
Participants
Start Date
November 15, 2017
Primary Completion Date
August 30, 2019
Study Completion Date
December 30, 2019
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.
Asian institute of Gastroenterology, Hyderabad
Asian Institute of Gastroenterology, India
OTHER