Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
AdventHealth
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.
Description
Endoscopic clipping devices are instruments designed to achieve tissue approximation during gastrointestinal endoscopy. Although endoscopic clips were initially developed for the primary purposes of accomplishing hemostasis of focal gastrointestinal bleeding, the indications for endoscopic clipping have expanded to include closure of perforations and fistulas, securing positioning of catheters and stents as well as to provide a radio-opaque markers to direct endoscopic, radiological, and surgical therapy. Traditionally, through-the-scope (TTS) clipping devices consist of 2 main components: me…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 protoc…
Interventions
- DeviceDAT Clip
All patients scheduled to undergo endoscopic procedures as medically indicated will be considered for the study. Data will be prospectively recorded according to the data collection form. The use of the DAT clip will be performed as medically indicated and consistent with the indications for endoscopic clipping (e.g., management of bleeding, treatment of fistulas, perforations, tissue approximation). The investigators on this project will also oversee the medical care of all patients that will participate in the study. Therefore, follow-up will be carried out as medically indicated and no clinical visits will be needed specifically for the purpose of this study.
Locations (2)
- AdventHealth OrlandoOrlando, Florida
- Parkview HealthFort Wayne, Indiana