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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Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Dennis Yang, MD · PRINCIPAL_INVESTIGATOR · AdventHealth
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.