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

Conditions

• Fistula
• GI Bleeding
• Perforated Bowel
• Perforation Bowel
• Perforation Colon
• Perforation Duodenal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DAT Clip — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Aug 31, 2022

Status verified

Jan 2025

Primary completion

Aug 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

250 participants (estimated)

Primary Outcome Measure

Complete closure rate. [ Time Frame: 12 months ]

Central Contacts

• Dennis Yang, MD
  407-303-2570
  [email protected]

Locations (2)

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