RecruitingNot Applicable

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

United States250 participantsStarted 2022-08-31

Plain-language summary

This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete closure rate.

Timeframe: 12 months

Trial details

NCT IDNCT05852457

SponsorAdventHealth

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08

Contact for this trial

Dennis Yang, MD

407-303-2570 Dennis.Yang.MD@adventhealth.com

View on ClinicalTrials.gov More GI Bleeding trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.