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

Summary

Gastric per-oral endoscopic pyloromyotomy (G-POEM) has been assessed as new modality for treatment of refractory gastroparesis. G-POEM is promising method, which is still under investigation as its safety and efficacy has not been established yet. The ideal closure technique in patients undergoing G-POEM needs to be established. Several techniques may be used for endoscopic mucosal closure: endoscopic clips, OTSC (over the scope clips), endo-loop based methods (KING closure) or endoscopic suture.

The aim of this prospective, open-label study is to compare efficacy and safety of two methods for incision closure in patients who undergo G-POEM: endoscopic clips vs. endoscopic suturing system (OverStitch).

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.

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine

  lead OTHER_GOV

Principal Investigators

• Jan Martinek · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

• Rastislav Hustak · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

• Zuzana Vackova · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

• Tomas Hucl · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

• Jan Usak · Universitary hospital Trnava, Slovak Republic

• Julius Spicak, Prof · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2020-12-01

Completion

2021-01-26

Countries

• Czechia

Study Locations