CompletedNot Applicable

MANTIS Endoscopic Clipping Study

United States, Canada240 participantsStarted 2023-03-28

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Number of Participants With Hemostasis of Active Bleeding

Timeframe: Index Procedure

Number of Participants With Prophylactic Hemostasis

Timeframe: Up to 30 Days after the index clipping procedure

Number of Lesions With Defect Closures

Timeframe: Index Procedure

Number of Participants With Serious Adverse Events

Timeframe: Up to 30 Days after the Endocsopic clipping procedure

Trial details

NCT IDNCT05653843

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08-07

Results submitted2025-07-01

View on ClinicalTrials.gov More Hemostasis trials