Fistula Clinical Trial
Official title:
Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
NCT number | NCT05852457 |
Other study ID # | 1931144 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2022 |
Est. completion date | February 2026 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | February 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Parkview Health | Fort Wayne | Indiana |
United States | AdventHealth Orlando | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
AdventHealth |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rate of Achievement of intended targeted therapy. | Defined as cases in which utilization of the DAT clip accomplished the intended treatment effect (e.g., hemostasis, perforation closure) | 12 months | |
Secondary | Procedural time. | Measure of procedural time associated with the operation of the DAT clip for its intended purpose. | 12 months | |
Secondary | Adverse Events | Measured based on the rate of adverse events with the procedure. | 12 months |
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