NCT05653843

MANTIS Endoscopic Clipping Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Hemostasis
• Perforation Colon
• Feeding Tube Complication
• Endoscopy

Interventions

Type	Name	Description
DEVICE	Endoscopic clip placement in the gastrointestinal tract.	The placement of a mechanical endoscopic clip in the gastrointestinal tract.

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-08-07
• Completion: 2024-08-07
• First posted: 2022-12-16
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

10 sites across 6 countries: United States, Canada, China, Hong Kong, India, Japan

Regulatory

• FDA-regulated device study