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NCT03679104
Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After G-POEM
NA trial testing Closure of mucosotomy using endoscopic clips in Gastroparesis in 40 participants. Completed in 26 January 2021.
1 December 2020
Quick facts
| Lead sponsor | Institute for Clinical and Experimental Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 November 2018 |
| Primary completion | 1 December 2020 |
| Estimated completion | 26 January 2021 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Closure of mucosotomy using endoscopic clips
- Closure of mucosotomy using OverStitch™ suturing device
Conditions studied
- Gastroparesis — all drugs for Gastroparesis →
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):
-
UEG Week 2019 Poster Presentations.
· 2019 · cited 5× · PMID 32213001 · DOI 10.1177/2050640619854671
Verify or expand the search:
- PubMed search for NCT03679104
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Institute for Clinical and Experimental Medicine trials
Trials by the same sponsor.
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- NCT06872255 — Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03679104 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute for Clinical and Experimental Medicine
- Last refreshed: 27 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03679104.
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