MANTIS Endoscopic Clipping Study

Last updated: December 18, 2024
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Blood Clots

Treatment

Endoscopic clip placement in the gastrointestinal tract.

Clinical Study ID

NCT05653843
92851066
  • All Genders

Study Summary

This study is intended to document clinical effectiveness and safety pertaining to use of a new endoscopic clipping device MANTIS™ when used for hemostasis, closure, anchoring and marking.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject indicated for endoscopic clipping per local standard of practice.

  • Willing and able to comply with the study procedures and provide written informedconsent to participate in the study.

Exclusion

Exclusion Criteria:

  • Subjects who are currently enrolled in another investigational study that woulddirectly interfere with the current study, without prior written approval from thesponsor.

  • Subjects who the investigator deems at risk for study device or procedure relatedcomplications per the Instructions for Use (IFU). where commercially available orthe Investigator Brochure (IB) for countries where the study device is not approved.

Study Design

Total Participants: 290
Treatment Group(s): 1
Primary Treatment: Endoscopic clip placement in the gastrointestinal tract.
Phase:
Study Start date:
March 28, 2023
Estimated Completion Date:
August 07, 2024

Study Description

To document clinical effectiveness and safety when used per indication within the GI tract for the purpose of:

  1. Endoscopic marking

  2. Hemostasis for:

    • Mucosal/sub-mucosal defects < 3 cm

    • Bleeding ulcers

    • Arteries < 2 mm

    • Polyps < 1.5 cm in diameter

    • Diverticula in the colon

    • Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection

  3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel

  4. As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively

Connect with a study center

  • St Michael's Hospital

    Toronto, Onterio M5B 1W8
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Shanghai Zhongshan Hospital

    Shanghai, Xuhui District 200031
    China

    Site Not Available

  • Prince of Wales Hospital The Chinese University of Hong Kong

    Hong Kong, Shatin
    Hong Kong

    Site Not Available

  • Asian Institute of Gastroenterology

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Showa University Koto Toyosu Hospital

    Tokyo, Koto-Ku 1358577
    Japan

    Site Not Available

  • Indiana University Medical Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.