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

NCT05852457 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

DAT 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.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Dennis Yang, MD · AdventHealth

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852457 on ClinicalTrials.gov