Clinical trial · Observational
Utility of OverStitch Sx After ESD
Prospective Study of Utility of OverStitch Sx Endoscopic Suturing System After ESD Procedure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Clinical/technical success rate utilizing endosuture
- timeFrame
- 2 years
- description
- To assess feasibility and technical success of using Overstitch Sx system for closure after ESD
- measure
- Rate of patients reported with bleeding/perforation post-ESD procedure
- timeFrame
- 2 years
- description
- Conduct follow-ups for risk of bleeding and perforation after closure
- measure
- Closure time after ESD
- timeFrame
- 2 years
- description
- Record time needed to close lesion
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Adults age 18-99, who are scheduled to undergo ESD procedure with possible mucosal defect closure. Exclusion Criteria: * Age is less than 18 years old
References
Publications (1)
- DERIVEDKeihanian T, Zabad N, Khalaf M, Abdel-Jaber W, Kim YI, Jawaid SA, Abidi WM, Marginean EC, Othman MO. Safety and efficacy of a novel suturing device for closure of large defects after endoscopic submucosal dissection (with video). Gastrointest Endosc. 2023 Sep;98(3):381-391. doi: 10.1016/j.gie.2023.04.006. Epub 2023 Apr 14. PMID 37061137