MANTIS Endoscopic Clipping Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05653843
• Collaborator: (none)
• Enrollment: 300
• Locations: 6
• Anticipated Duration (Months): 11
• Patients Per Site: 50
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemostasis; Perforation Colon; Feeding Tube Complication; Endoscopy	Device: Endoscopic clip placement in the gastrointestinal tract.

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

1. Anchoring to affix jejunal feeding tubes to the wall of the small bowel

2. As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
• Anticipated Study Start Date: Feb 28, 2023
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Jan 30, 2024

Outcome Measures

Primary Outcome Measures

1. Hemostasis of active bleeding [Procedure]

   Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure

2. 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

3. Defect closure [Procedure]

   Clinical success defined as defect closure

4. Affixing Jejunal Feeding tubes [Procedure]

   Clinical success defined as affixing Jejunal Feeding tubes to the wall of the small bowel

5. Endoscopic Marking [Procedure]

   Clinical success defined as endoscopic Marking

6. Resolution of the indication for clip placement [Procedure]

   Clinical success defined as ability to complete desired indication of clip for other usage

7. 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

1. Clip deployment [Procedure]

   Incidents of success at placement defined as ability to deploy the endoscopic clips in satisfactory position

2. Closure [Procedure]

   Incidents of ability to approximate defect edges for secured closure.

3. 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)

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
4	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
5	St Michael's Hospital	Toronto	Onterio	Canada	M5B 1W8
6	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec	Canada	H2X 0A9

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Daniel von Renteln, MD, Centre hospitalier de l'Université de Montréal (CHUM)
• Principal Investigator: Jeff Mosko, MD, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT05653843
• Other Study ID Numbers: 92851066
• First Posted: Dec 16, 2022
• Last Update Posted: Jan 25, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Jan 25, 2023