MANTIS Endoscopic Clipping Study

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.

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Key information

Conditions

Hemostasis Endoscopy Feeding Tube Complication Perforation Colon

Sex eligibility

All sexes

Study type

Observational

Primary location

St Michael's Hospital, Toronto, Onterio, Canada

About this study

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

Endoscopic marking
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
Anchoring to affix jejunal feeding tubes to the wall of the small bowel
As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Endoscopic clip placement in the gastrointestinal tract.

Device

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

Primary outcomes

Number of Participants With Hemostasis of Active Bleeding

Time frame: Index Procedure

Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Number of Participants With Prophylactic Hemostasis

Time frame: Up to 30 Days after the index clipping procedure

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
Number of Lesions With Defect Closures

Time frame: Index Procedure

Clinical success defined as defect closure
Number of Participants With Serious Adverse Events

Time frame: Up to 30 Days after the Endocsopic clipping procedure

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Dec 16, 2022
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed