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NCT04361227
Utility of OverStitch Sx After ESD
trial in Gastrointestinal Neoplasms in 33 participants. Completed in 20 October 2022.
31 May 2022
Quick facts
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 33 |
| Start date | 2 July 2020 |
| Primary completion | 31 May 2022 |
| Estimated completion | 20 October 2022 |
| Sites | 1 location across United States |
Conditions studied
- Gastrointestinal Neoplasms — all drugs for Gastrointestinal Neoplasms →
Sponsor
Baylor College of Medicine
Who can join
Adults 18 to 99, any sex, with Gastrointestinal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective study where the investigators will make a database of all the patients who have received this procedure and will document various outcomes (i.e. number of sutures used, number of clips (if used), time required to close, complications/ issues). No changes will be done to the participant's procedure and the participants are asked to consent for the use of the participant's data in our database. The participants are being asked to be in this research study because the participants have been scheduled to undergo an ESD procedure at Baylor St. Luke Medical Center and will most likely require clipping and/or suturing following intervention. This study is important because this is a relatively new procedure; although it is a part of the participant's standard of care, it is not done in many hospitals. The investigators would like to document the outcomes and results of such procedures to continuously improve our standard of care.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and efficacy of a novel suturing device for closure of large defects after endoscopic submucosal dissection (with video).
Keihanian T, Zabad N, Khalaf M, Abdel-Jaber W, et al · · 2023 · cited 17× · PMID 37061137 · DOI 10.1016/j.gie.2023.04.006
Verify or expand the search:
- PubMed search for NCT04361227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04361227 (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 Baylor College of Medicine
- Last refreshed: 15 February 2023
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/NCT04361227.
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