Clinical trial NCT05653843: MANTIS Endoscopic Clipping Study
Official title: MANTIS Clip Study: a Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemostasis
Perforation Colon
Feeding Tube Complication
Endoscopy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 290
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population will be patients usually treated for the device indication.

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.

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

Eligibility criteria: 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 outcomes:
measure: Hemostasis of active bleeding
timeFrame: Procedure
measure: Prophylactic hemostasis
timeFrame: 30 Days
measure: Defect closure
timeFrame: Procedure
measure: Affixing Jejunal Feeding tubes
timeFrame: Procedure
measure: Endoscopic Marking
timeFrame: Procedure
measure: Resolution of the indication for clip placement
timeFrame: Procedure
measure: Serious Adverse Events
timeFrame: 30 Days
Secondary outcomes:
measure: Clip deployment
timeFrame: Procedure
measure: Closure
timeFrame: Procedure
measure: Delayed bleeding
timeFrame: 30 Days
measure: Active bleeding hemostasis
timeFrame: 7 Days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Onterio
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Xuhui District
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital The Chinese University of Hong Kong
state: Shatin
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
city: Tokyo
country: Japan
facility: Showa University Koto Toyosu Hospital
state: Koto-Ku
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel von Renteln, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Jeff Mosko, MD
role: PRINCIPAL_INVESTIGATOR
References: