Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorAdventHealth
Academic / other
Locations2 sites (Orlando, Florida and 1 other locations)
StatusRecruiting
StartedAugust 31, 2022
Main results expectedAugust 2027
Study endsDecember 2027
Registry record updatedOctober 15, 2026
Trial IDNCT05852457 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.