Clinical trial · Interventional
Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
NCT05163665CI-TRIAL-00074035completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Closure type | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Through-the-Scope clip group
- description
- Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.
- interventionNames
- Procedure: Closure type
- type
- ACTIVE_COMPARATOR
- label
- X-Tack suturing group
- description
- Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.
- interventionNames
- Procedure: Closure type
Primary outcomes (1)
- measure
- Cost of each closure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is greater than or equal to 18 years of age. * Patient can provide informed consent. * Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion. * Post resection defect \> 3cm. * Lesion 2cm or greater from the dentate line. Exclusion Criteria: * Patient is \< 18 years of age. * Patient refused and/or unable to provide consent. * Patient is pregnant. * Patient is currently incarcerated
References
Publications (1)
- DERIVEDJawaid S, Khalaf M, Ayoub F, Zabad N, Fikry A, Daba G, Mercado M, Keihanian T, Othman M. RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large post-endoscopic resection defects. Surg Endosc. 2025 Aug;39(8):5442-5453. doi: 10.1007/s00464-025-11876-1. Epub 2025 Jul 10. PMID 40640617