Recruiting

Endoscopic Closure

Sponsor:

AdventHealth

Code:

NCT05852457

Conditions

GI Bleeding

Perforation Colon

Perforation Bowel

Perforation Duodenal

Perforated Bowel

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DAT Clip

Study Details

Brief 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

Study ID

NCT05852457

Start date

Aug 31, 2022

Status verified date

Jan, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Complete closure rate. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Dennis Yang, MD

407-303-2570Dennis.Yang.MD@adventhealth.com

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Dennis Yang, MD

407-303-2570Dennis.Yang.MD@adventhealth.com

Diana Paredes, RN, BSN

407-303-9736Diana.Paredes@adventhealth.com

Parkview Health

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Neil Sharma, MD

Neil.Sharma@parkview.com

Christina Zelt, MSN, RN,CRC

260-266-4153Christina.Zelt@parkview.com

More Information

Sponsor

AdventHealth

Last update posted

Oct 8, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2025-10-08.