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

Launched by ADVENTHEALTH · May 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a medical tool called the Dual Action Tissue (DAT) Clip, which is used during endoscopic procedures to help close wounds in the gastrointestinal (GI) tract, such as those caused by bleeding, perforations, or fistulas. The goal of the study is to gather information on how well this clip works when used as part of routine medical care for patients undergoing endoscopy, which is a procedure that allows doctors to look inside the GI tract using a flexible tube with a camera.

To be eligible for this trial, participants need to be at least 18 years old and scheduled for an endoscopic procedure where the use of the DAT clip is necessary. This could include treating bleeding, closing perforations, or helping with tissue repair after certain types of surgeries. Patients who cannot undergo endoscopy for medical reasons or are involved in other research studies that could affect the outcomes of this trial will not be able to participate. If eligible, participants can expect to have their routine care documented without any experimental treatments being introduced.

Gender

ALL

Eligibility 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.