HemostasisNCT05653843
MANTIS Endoscopic Clipping Study
An observational study of Hemostasis and Perforation Colon, run by Boston Scientific Corporation at 10 sites in 6 countries.
Trial summary
This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited to hemostasis, closure, anchoring and marking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemostasis, Perforation Colon, Feeding Tube Complication
- What is being tested?
- Endoscopic clip placement in the gastrointestinal tract.
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 28 Mar 2023to 7 Aug 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population will be patients usually treated for the device indication.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Indiana University Medical Center
Indianapolis, Indiana, 46202
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Canada2 sites
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
St Michael's Hospital
Toronto, Onterio, M5B 1W8
Hong Kong1 site
Prince of Wales Hospital The Chinese University of Hong Kong
Hong Kong, Shatin
About this study
Official title: MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited to hemostasis, closure, anchoring and marking.
Read the detailed description
To document clinical effectiveness and safety when used per indication within the GI tract for the purpose of:
- Endoscopic marking
- 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
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively
- Conditions
- Hemostasis, Perforation Colon, Feeding Tube Complication, Endoscopy
- Being tested
- Endoscopic clip placement in the gastrointestinal tract.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic clip placement in the gastrointestinal tract.Device
The placement of a mechanical endoscopic clip in the gastrointestinal tract.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hemostasis of Active Bleeding
Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Measured: Index Procedure
Number of Participants With 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
Measured: Up to 30 Days after the index clipping procedure
Number of Lesions With Defect Closures
Clinical success defined as defect closure
Measured: Index Procedure
Number of Participants With Serious Adverse Events
Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure
Measured: Up to 30 Days after the Endocsopic clipping procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start28 Mar 2023
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel von Renteln, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Jeff Mosko, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653843
- Sponsor's protocol ID
- 92851066
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2022
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mosko JD, Al-Haddad M, Pohl H, Kumta NA, Chan SM, Ryou M, Nabi Z, Zhou PH, Inoue H, Peetermans JA, Rousseau MJ, von Renteln D. Through-the-scope clip with anchor prongs for defect closure following myotomy, resection, anti-reflux mucosectomy, fistula management, or bleeding. Endosc Int Open. 2026 Jan 27;14:a27734910. doi: 10.1055/a-2773-4910. eCollection 2026.
PubMed 41988030von Renteln D, Rex DK, Pohl H, Kumta NA, Chan S, Ryou M, Nabi Z, Zhou PH, Inoue H, Peetermans JA, Rousseau MJ, Mosko JD. High Rates of Defect Closure After Resection of Large Nonpedunculated Colorectal Lesions Using a Through-The-Scope Clip With Anchor Prongs. United European Gastroenterol J. 2026 Feb;14(1):e70164. doi: 10.1002/ueg2.70164.
PubMed 41442239
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
- ClinicalTrials.gov ID
- NCT05653843
- Acronym / sponsor ID
- 92851066
- Conditions
- Hemostasis, Perforation Colon, Feeding Tube Complication, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited to 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:
- Endoscopic marking
- 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
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population will be patients usually treated for the device indication.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic clip placement in the gastrointestinal tract.The placement of a mechanical endoscopic clip in the gastrointestinal tract. | Device | – |
Primary outcome
Number of Participants With Hemostasis of Active Bleeding
Time frame: Index Procedure
Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Number of Participants With Prophylactic Hemostasis
Time frame: Up to 30 Days after the index clipping procedure
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
Number of Lesions With Defect Closures
Time frame: Index Procedure
Clinical success defined as defect closure
Number of Participants With Serious Adverse Events
Time frame: Up to 30 Days after the Endocsopic clipping procedure
Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41988030Mosko JD, Al-Haddad M, Pohl H, Kumta NA, Chan SM, Ryou M, Nabi Z, Zhou PH, Inoue H, Peetermans JA, Rousseau MJ, von Renteln D. Through-the-scope clip with anchor prongs for defect closure following myotomy, resection, anti-reflux mucosectomy, fistula management, or bleeding. Endosc Int Open. 2026 Jan 27;14:a27734910. doi: 10.1055/a-2773-4910. eCollection 2026.
- Derived from this study: PubMed 41442239von Renteln D, Rex DK, Pohl H, Kumta NA, Chan S, Ryou M, Nabi Z, Zhou PH, Inoue H, Peetermans JA, Rousseau MJ, Mosko JD. High Rates of Defect Closure After Resection of Large Nonpedunculated Colorectal Lesions Using a Through-The-Scope Clip With Anchor Prongs. United European Gastroenterol J. 2026 Feb;14(1):e70164. doi: 10.1002/ueg2.70164.
- Individual participant dataSharing planned: No
Related trials for Hemostasis
Not yet recruitingObservational study
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
Hemostasis, Distal Radial Artery Access (dTRA)
Not yet recruiting
TR Band Combined With Adrenaline Drops Versus TR Band Alone for Radial Artery Hemostasis After Cardiac Catheterization
Radial Artery Hemostasis
Recruiting
Efficacy and Safety of NasoAid® After Nasal Surgery
Nasal Surgery, Hemostasis
Active, not recruiting
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Hemostasis, Hemostatic Techniques
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel von Renteln, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Jeff Mosko, MD principal investigator
Unity Health Toronto
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis and Perforation Colon, run by Boston Scientific Corporation at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, China, Hong Kong, India and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hemostasis of Active Bleeding (time frame: Index Procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05653843, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.