MANTIS Endoscopic Clipping Study

Completed

Conditions: Hemostasis
Feeding Tube Complication
Endoscopy
Perforation Colon

Brief 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

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Prophylactic Hemostasis	Up to 30 Days after the index clipping procedure	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
Number of Participants With Hemostasis of Active Bleeding	Index Procedure	Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Number of Lesions With Defect Closures	Index Procedure	Clinical success defined as defect closure
Number of Participants With Serious Adverse Events	Up to 30 Days after the Endocsopic clipping procedure	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

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
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
St Michael's Hospital
🇨🇦
Toronto, Onterio, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦
Montréal, Quebec, Canada
Shanghai Zhongshan Hospital
🇨🇳
Shanghai, Xuhui District, China
Prince of Wales Hospital The Chinese University of Hong Kong
🇭🇰
Hong Kong, Shatin, Hong Kong
Asian Institute of Gastroenterology
🇮🇳
Hyderabad, Telangana, India
Showa University Koto Toyosu Hospital
🇯🇵
Tokyo, Koto-Ku, Japan
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States