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

What this Trial Is About

Researchers are studying the use of the Dual Action Tissue (DAT) clip, a new endoscopic device designed to close large tissue defects in the gastrointestinal (GI) tract during routine medical care. The study aims to document how well the DAT clip performs in real-world settings, focusing on its role in managing GI bleeding, perforations, fistulas, and tissue gaps following procedures such as endoscopic mucosal resection or myotomy. This observational study does not involve experimental treatments but collects data prospectively to evaluate the clip's clinical utility. The DAT clip is a specially designed three-armed device approved by the FDA, with two independently operating arms that can open up to 60 degrees to securely clamp the edges of tissue defects. It is used during standard endoscopic procedures whenever closure of a defect is needed. Patients scheduled for such procedures may have the DAT clip applied as part of their medical care. No additional clinical visits are required solely for study purposes, and follow-up care is managed according to standard medical indications. Participants will undergo their usual endoscopic procedures, during which data will be recorded about the use of the DAT clip. Researchers will track important outcomes including the rate of complete closure of tissue defects within 12 months, the success in achieving targeted therapy, procedure times, and any adverse events. The study involves no extra visits beyond routine care, and the total monitoring period extends up to one year to assess the clip's performance and safety.

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