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

NCT05852457 | Recruiting FDA Device

• 1 other identifier: 1931144
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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; Fistula

Outcome Measures

Primary Outcomes (1)

• Complete closure rate.

  Cases in which complete tissue approximation is achieved with the use of the DAT clip- no substantial gaps are visible in the closure line.

  12 months

Secondary Outcomes (3)

• Rate of Achievement of intended targeted therapy.

  12 months

• Procedural time.

  12 months

• Adverse Events

  12 months

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled to undergo endoscopic procedures at participating centers as medically indicated will be considered for the study.

You may qualify if:

• 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)

You may not qualify if:

• Any contraindications to performing endoscopy.
• Participants in another research protocol that could interfere or influence the outcomes measures of the present study.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (2)

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Parkview Health

Fort Wayne, Indiana, 46845, United States

RECRUITING

Related Publications (4)

• Technology Assessment Committee; Chuttani R, Barkun A, Carpenter S, Chotiprasidhi P, Ginsberg GG, Hussain N, Liu J, Silverman W, Taitelbaum G, Petersen B. Endoscopic clip application devices. Gastrointest Endosc. 2006 May;63(6):746-50. doi: 10.1016/j.gie.2006.02.042. No abstract available.

  PMID: 16650531 BACKGROUND

• Wang TJ, Aihara H, Thompson AC, Schulman AR, Thompson CC, Ryou M. Choosing the right through-the-scope clip: a rigorous comparison of rotatability, whip, open/close precision, and closure strength (with videos). Gastrointest Endosc. 2019 Jan;89(1):77-86.e1. doi: 10.1016/j.gie.2018.07.025. Epub 2018 Jul 27.

  PMID: 30056253 BACKGROUND

• Zhang Q, Jin HY, Shen ZH, Ma XJ, Li CQ, Tang Z, Bai Y, Wang Z. Novel through-the-scope twin clip for the closure of GI wounds: the first experimental survival study in pigs (with videos). Gastrointest Endosc. 2021 Oct;94(4):850-858.e2. doi: 10.1016/j.gie.2021.04.027. Epub 2021 May 7.

  PMID: 33965383 BACKGROUND

• Mohammed A, Gonzaga ER, Hasan MK, Saeed A, Friedland S, Bilal M, Sharma N, Jawaid S, Othman M, Khalaf MA, Hwang JH, Viana A, Singh S, Hayat M, Cosgrove ND, Jain D, Arain MA, Kadkhodayan KS, Yang D. Low delayed bleeding and high complete closure rate of mucosal defects with the novel through-the-scope dual-action tissue clip after endoscopic resection of large nonpedunculated colorectal lesions (with video). Gastrointest Endosc. 2024 Jan;99(1):83-90.e1. doi: 10.1016/j.gie.2023.07.025. Epub 2023 Jul 21.

  PMID: 37481003 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Intestinal Perforation; Fistula

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Pathological Conditions, Anatomical

Study Officials

• Dennis Yang, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Yang, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: August 31, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)