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NCT03679104

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

Completed NA Last updated 27 January 2021
What this trial tests

NA trial testing Closure of mucosotomy using endoscopic clips in Gastroparesis in 40 participants. Completed in 26 January 2021.

Timeline
1 November 2018
Primary endpoint
1 December 2020
26 January 2021

Quick facts

Lead sponsorInstitute for Clinical and Experimental Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment40
Start date1 November 2018
Primary completion1 December 2020
Estimated completion26 January 2021
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Institute for Clinical and Experimental Medicine

Who can join

Adults 18 to 90, any sex, with Gastroparesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. UEG Week 2019 Poster Presentations.
    · 2019 · cited 5× · PMID 32213001 · DOI 10.1177/2050640619854671

Verify or expand the search:

Other recruiting trials for Gastroparesis

Currently open trials in the same condition.

Other Institute for Clinical and Experimental Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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