Completed

MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2023
See protocol details

Summary

Principal SponsorBoston Scientific Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2023

Actual date on which the first participant was enrolled.

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

Official TitleMANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
NCT05653843
Principal SponsorBoston Scientific Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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.
2 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Indiana University Medical Center

Indianapolis, United StatesOpen Indiana University Medical Center in Google Maps
Suspended

Brigham and Women's Hospital

Boston, United States
Suspended

Dartmouth Hitchcock Medical Center

Lebanon, United States
Suspended

Icahn School of Medicine at Mount Sinai

New York, United States
Completed10 Study Centers