MANTIS Endoscopic Clipping Study

Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653843
• Other study ID #: 92851066
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: Boston Scientific Corporation
• Contact: Andrea Burbage
• Phone: 7812544679
• Email: andrea.burbage[@]bsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Endoscopy
• Feeding Tube Complication
• Hemostasis
• Perforation Colon

Intervention

Device:
• Endoscopic clip placement in the gastrointestinal tract.
The placement of a mechanical endoscopic clip in the gastrointestinal tract.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	St Michael's Hospital	Toronto	Onterio
China	Shanghai Zhongshan Hospital	Shanghai	Xuhui District
Hong Kong	Prince of Wales Hospital The Chinese University of Hong Kong	Hong Kong	Shatin
India	Asian Institute of Gastroenterology	Hyderabad	Telangana
Japan	Showa University Koto Toyosu Hospital	Tokyo	Koto-Ku
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  China,  Hong Kong,  India,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis of active bleeding	Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure	Procedure
Primary	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	30 Days
Primary	Defect closure	Clinical success defined as defect closure	Procedure
Primary	Affixing Jejunal Feeding tubes	Clinical success defined as affixing Jejunal Feeding tubes to the wall of the small bowel	Procedure
Primary	Endoscopic Marking	Clinical success defined as endoscopic Marking	Procedure
Primary	Resolution of the indication for clip placement	Clinical success defined as ability to complete desired indication of clip for other usage	Procedure
Primary	Serious Adverse Events	Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure	30 Days
Secondary	Clip deployment	Incidents of success at placement defined as ability to deploy the endoscopic clips in satisfactory position	Procedure
Secondary	Closure	Incidents of ability to approximate defect edges for secured closure.	Procedure
Secondary	Delayed bleeding	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)	30 Days
Secondary	Active bleeding hemostasis	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	7 Days