Evaluating a new clip for closing gastrointestinal defects
Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
This study is testing a new clip designed to close larger holes in the gastrointestinal tract during endoscopic procedures to see how well it works for patients with GI issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Trial ID | NCT05852457 on ClinicalTrials.gov |
What this trial studies
This observational study aims to document the performance of the Dual Action Tissue (DAT) clip during standard endoscopic procedures for patients with gastrointestinal issues. The DAT clip is designed to effectively close larger defects and perforations in the GI tract, which traditional clips may struggle to manage. By collecting data from multiple centers, the study seeks to assess the clinical utility of this innovative device in real-world settings without introducing experimental interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for endoscopic procedures where clip closure is clinically indicated.
Not a fit: Patients with contraindications to endoscopy or those participating in other conflicting research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of endoscopic procedures for patients with gastrointestinal perforations and bleeding.
How similar studies have performed: While the use of endoscopic clips is established, the specific application of the DAT clip for larger defects represents a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Patients scheduled to undergo endoscopic procedures as part of their routine care in which endoscopic clip closure is clinically indicated: Treatment of bleeding Treatment of perforation and/or fistulas Tissue approximation for mucosal gaps associated with endoscopic resection (e.g., endoscopic mucosal resection, endoscopic submucosal dissection) or third space endoscopy (e.g., peroral endoscopic myotomy in the gastrointestinal tract) Exclusion Criteria: * Any contraindications to performing endoscopy. * Participants in another research protocol that could interfere or influence the outcomes measures of the present study.
Where this trial is running
Orlando, Florida and 1 other locations
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Parkview Health — Fort Wayne, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Dennis Yang, MD — AdventHealth
- Study coordinator: Dennis Yang, MD
- Email: Dennis.Yang.MD@adventhealth.com
- Phone: 407-303-2570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.