MANTIS Endoscopic Clipping Study

NCT05653843 | Completed Results FDA Device

• 1 other identifier: 92851066
• Study Type: observational
• Target: 240
• Locations: 6 countries
• Sites: 10

Brief Summary

This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited to hemostasis, closure, anchoring and marking.

Conditions

Hemostasis; Perforation Colon; Feeding Tube Complication; Endoscopy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Hemostasis of Active Bleeding

  Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure

  Index Procedure

• Number of Participants With Prophylactic Hemostasis

  Clinical success defined as hemostasis as a prophylactic measure to minimize risk of a delayed bleeding post lesion resection, defined as absence of a bleeding SAE up to 30 days after the index clipping procedure

  Up to 30 Days after the index clipping procedure

• Number of Lesions With Defect Closures

  Clinical success defined as defect closure

  Index Procedure

• Number of Participants With Serious Adverse Events

  Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure

  Up to 30 Days after the Endocsopic clipping procedure

Interventions

Endoscopic clip placement in the gastrointestinal tract. DEVICE

The placement of a mechanical endoscopic clip in the gastrointestinal tract.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population will be patients usually treated for the device indication.

You may qualify if:

• Subject indicated for endoscopic clipping per local standard of practice.
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

You may not qualify if:

• Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
• Subjects who the investigator deems at risk for study device or procedure related complications per the Instructions for Use (IFU). where commercially available or the Investigator Brochure (IB) for countries where the study device is not approved.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (10)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

St Michael's Hospital

Toronto, Onterio, M5B 1W8, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

Shanghai Zhongshan Hospital

Shanghai, Xuhui District, 200031, China

Location

Prince of Wales Hospital The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Showa University Koto Toyosu Hospital

Tokyo, Koto-Ku, 1358577, Japan

Location

Related Publications (1)

• von Renteln D, Rex DK, Pohl H, Kumta NA, Chan S, Ryou M, Nabi Z, Zhou PH, Inoue H, Peetermans JA, Rousseau MJ, Mosko JD. High Rates of Defect Closure After Resection of Large Nonpedunculated Colorectal Lesions Using a Through-The-Scope Clip With Anchor Prongs. United European Gastroenterol J. 2026 Feb;14(1):e70164. doi: 10.1002/ueg2.70164.

  PMID: 41442239 DERIVED

Results Point of Contact

• Title: Andrea Burbage, Principal Clinical Trial Manager
• Organization: Boston Scientific

andrea.burbage@bsci.com

7812544679

Study Officials

• Daniel von Renteln, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• Jeff Mosko, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: December 16, 2022
• Study Start: March 28, 2023
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (4); HK (1); IN (1); JP (1); CN (1)