MANTIS Endoscopic Clipping Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopy; Hemostasis; Perforation Colon; Feeding Tube Complication
• Intervention / Treatment: 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
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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Andrea Burbage; Phone Number: 7812544679; Email: andrea.burbage@bsci.com
• Study Contact Backup: Name: Huma Preston; Phone Number: 5086834813; Email: huma.preston@bsci.com

Study Locations

• Canada
  • Onterio
    • Toronto, Onterio, Canada, M5B 1W8
      • Recruiting
      • St Michael's Hospital
      • Contact: Jeff Mosko, MD; Email: Jeff.Mosko@unityhealth.to
      • Principal Investigator: Jeff Mosko, MD
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • Completed
      • Centre Hospitalier de l'Université de Montréal (CHUM)
• China
  • Xuhui District
    • Shanghai, Xuhui District, China, 200031
      • Not yet recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Ping Hong Zhou, MD; Phone Number: +86 21 6404 1990; Email: zhou.pinghong@zs-hospital.sh.cn
      • Principal Investigator: Ping Hong Zhou, MD
• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong
      • Recruiting
      • Prince of Wales Hospital The Chinese University of Hong Kong
      • Contact: Shannon Chan, MD; Email: shannonchan@surgery.cuhk.edu.hk
      • Principal Investigator: Shannon Chan, MD
• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology
      • Contact: Nabi Zaheer, MD; Email: zaheernabi1978@gmail.com
      • Principal Investigator: Nabi Zaheer, MD
• Japan
  • Koto-Ku
    • Tokyo, Koto-Ku, Japan, 1358577
      • Not yet recruiting
      • Showa University Koto Toyosu Hospital
      • Contact: Harohiro Inoue, MD; Email: Haru.inoue@med.showa-u.ac.jp
      • Principal Investigator: Harohiro Inoue, MD
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Indiana University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Marvin Ryou, MD; Email: mryou@bwh.harvard.edu
      • Principal Investigator: Marvin Ryou, MD
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth Hitchcock Medical Center
      • Contact: Heiko Pohl, MD; Email: heiko.pohl@dartmouth.edu
      • Principal Investigator: Heiko Pohl, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Nikhil Kumta, MD; Email: Nikhil.kumta@mssm.edu
      • Principal Investigator: Nikhil Kumta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Population will be patients usually treated for the device indication.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis of active bleeding	Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure	Procedure
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
Defect closure	Clinical success defined as defect closure	Procedure
Affixing Jejunal Feeding tubes	Clinical success defined as affixing Jejunal Feeding tubes to the wall of the small bowel	Procedure
Endoscopic Marking	Clinical success defined as endoscopic Marking	Procedure
Resolution of the indication for clip placement	Clinical success defined as ability to complete desired indication of clip for other usage	Procedure
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clip deployment	Incidents of success at placement defined as ability to deploy the endoscopic clips in satisfactory position	Procedure
Closure	Incidents of ability to approximate defect edges for secured closure.	Procedure
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
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 92851066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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