Evaluating the DAT Clip for GI Bleeding and Perforations

This study is looking at how well a device called the Dual Action Tissue (DAT) Clip works in real-world medical care. The DAT Clip is a special tool used during endoscopy (a procedure where a thin, flexible tube with a camera is inserted into the body) to close up issues like bleeding in the digestive system (GI Bleeding) or holes (perforations) in the colon, bowel, or duodenum. This study will observe 250 patients aged 18 or older who are already scheduled for endoscopic procedures where clip closure is needed. Researchers will record information about how the DAT Clip performs. The main goal is to see how often complete closure is achieved, measured 12 months after the procedure. This is an observational study, meaning no experimental treatments are given; you would receive the DAT Clip as part of your standard medical care if your doctor determines it's appropriate.

Study design
This is an observational study involving 250 participants. It is designed to record data on the performance of the DAT Clip as part of standard medical care.
What's involved
You would undergo an endoscopic procedure as medically indicated, during which the DAT Clip may be used. Data related to this procedure will be recorded.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the complete closure rate at 12 months, suggesting follow-up for at least that long.

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NCT05852457

Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip

Recruiting
Not specifiedAges 18+Observational
AdventHealth
~250 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:DAT Clip

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete closure rate.
Measured over 12 months
GI Bleeding
Perforation Colon
Perforation Bowel
Perforation Duodenal
Perforated Bowel
Fistula
2 sites across 2 states
Florida1
Indiana1
  • Dennis Yang, MD · PRINCIPAL_INVESTIGATOR · AdventHealth

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Eligibility criteria

Inclusion

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:

Exclusion

Any contraindications to performing endoscopy.
Participants in another research protocol that could interfere or influence the outcomes measures of the present study.
  • Complete closure rate.12 months

    Cases in which complete tissue approximation is achieved with the use of the DAT clip- no substantial gaps are visible in the closure line.