MANTIS Endoscopic Clipping Study

Completed

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

• Registration Number: NCT05653843
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

This study is intended to document clinical effectiveness and safety pertaining to use of a new endoscopic clipping device MANTIS™ when used for 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

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Study Start: 2023-03-28
• Primary Completion: 2024-08-07
• Study Completion: 2024-08-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prophylactic hemostasis	30 Days	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
Affixing Jejunal Feeding tubes	Procedure	Clinical success defined as affixing Jejunal Feeding tubes to the wall of the small bowel
Hemostasis of active bleeding	Procedure	Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Defect closure	Procedure	Clinical success defined as defect closure
Endoscopic Marking	Procedure	Clinical success defined as endoscopic Marking
Resolution of the indication for clip placement	Procedure	Clinical success defined as ability to complete desired indication of clip for other usage
Serious Adverse Events	30 Days	Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure

Secondary Outcome Measures

Name	Time	Method
Clip deployment	Procedure	Incidents of success at placement defined as ability to deploy the endoscopic clips in satisfactory position
Closure	Procedure	Incidents of ability to approximate defect edges for secured closure.
Delayed bleeding	30 Days	Incidents of post procedural bleeding, defined as a severe bleeding event that required hospitalization, a blood transfusion (\>5 units), or another invasive intervention (angiographic or surgery)
Active bleeding hemostasis	7 Days	Rate of patients requiring additional modalities of hemostasis. Report of hemostasis of active bleeding 7 days after the index study procedure, defined as ability to stop the active bleed at the time of the study procedure and/or with additional clipping procedures to provide hemostasis of continued or recurrent bleeding within 7 days of the index study procedure

Trial Locations

Locations (10)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

St Michael's Hospital; 🇨🇦 Toronto, Onterio, Canada

Showa University Koto Toyosu Hospital; 🇯🇵 Tokyo, Koto-Ku, Japan

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Xuhui District, China

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India

Prince of Wales Hospital The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Shatin, Hong Kong

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada