Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After G-POEM

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 1, 2018

Primary Completion Date

December 1, 2020

Study Completion Date

January 26, 2021

Conditions
Gastroparesis
Interventions
PROCEDURE

Closure of mucosotomy using endoscopic clips

Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done using endoscopic clips. These are used in endoscopy to mechanically close two mucosal surfaces without the need for surgery and suturing. In this study, the following endoclips may be used: Resolution 360™ Clip (Boston Scientific), QuickClip Pro™(Olympus) or Instinct™ Endoscopic Hemoclip (Cook Medical).

PROCEDURE

Closure of mucosotomy using OverStitch™ suturing device

Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done by OverStitch™ (Apollo Endosurgery Inc., Austin, Texas, USA), which is a suturing device that enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures through a flexible endoscope.

Trial Locations (1)

14021

Institute for Clinical and Experimental Medicine, Prague

All Listed Sponsors
lead

Institute for Clinical and Experimental Medicine

OTHER_GOV

NCT03679104 - Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After G-POEM | Biotech Hunter | Biotech Hunter