Endoscopy Clinical Trial
Official title:
MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
NCT number | NCT05653843 |
Other study ID # | 92851066 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 28, 2023 |
Est. completion date | July 30, 2024 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States, Canada, China, Hong Kong, India, Japan,
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 |
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