Evaluating a new clip for closing gastrointestinal defects
Official title: Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
Run by AdventHealth · NCT05852457 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | AdventHealth Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 31, 2022 |
| Main results expected | August 2027 |
| Study ends | December 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT05852457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are scheduled for endoscopic procedures where clip closure is clinically indicated.
✕Probably not a fit
Patients with contraindications to endoscopy or those participating in other conflicting research protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis
This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.
-
Preventing hernias after emergency surgery
See how often adults who have emergency abdominal surgery develop postoperative hernias and which risk factors they have.
-
Evaluating pancreatic fistula rates after surgery using a specific stapler
This study is testing if using a specific stapler during pancreas surgery can lower the chances of complications like pancreatic fistulas in patients.
-
Evaluating the ERAS program's impact on recovery after pancreatic surgery
This study is testing if following a special recovery program can help people recover better after pancreatic surgery.
-
Using insertable devices to manage obstetric fistula
This study tests whether a new vaginal cup can help women with urinary incontinence from obstetric fistula feel better while they wait for surgery.
-
High-dose oral omeprazole for treating peptic ulcer bleeding
This study tests if taking high-dose oral omeprazole can help prevent re-bleeding in patients with peptic ulcers just like the more expensive intravenous treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.