MANTIS Endoscopic Clipping Study

Boston Scientific Corporation240 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Hemostasis Perforation Colon Feeding Tube Complication Endoscopy

Interventions

Endoscopic clip placement in the gastrointestinal tract.DEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (10)

Indiana University Medical Center

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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

Time frame: 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

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

Number of Lesions With Defect Closures

Clinical success defined as defect closure

Time frame: 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

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

Data from ClinicalTrials.gov

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