MANTIS Endoscopic Clipping Study

Boston Scientific

Status: Completed

Conditions: Hemostasis; Feeding Tube Complication; Perforation Colon; Endoscopy

Treatments: Device: Endoscopic clip placement in the gastrointestinal tract.

Study type: Observational

Funder types: Industry

Identifiers

NCT05653843

92851066

Details and patient eligibility

About

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.

Full description

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

Enrollment: 240 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design