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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 MANTISâ„¢ including but not limited to hemostasis, closure, anchoring and marking.
To document clinical effectiveness and safety when used per indication within the GI tract for the purpose of:
Endoscopic marking
Hemostasis for:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic clip placement in the gastrointestinal tract. | Device | The placement of a mechanical endoscopic clip in the gastrointestinal tract. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Up to 30 Days after the index clipping procedure |
| Number of Lesions With Defect Closures | Clinical success defined as defect closure | 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 | Up to 30 Days after the Endocsopic clipping procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Population will be patients usually treated for the device indication.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel von Renteln, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Jeff Mosko, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41988030 | Derived | 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. | |
| 41442239 |
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| ID | Title | Description |
|---|---|---|
| FG000 | MANTIS Clipping Study | Subject indicated for endoscopic clipping per local standard of practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MANTIS Clipping Study | Subject indicated for endoscopic clipping per local standard of practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Index Procedure |
|
|
Up to 36 days post index procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MANTIS Clipping Study | Subject indicated for endoscopic clipping per local standard of practice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Caecal perforation | Gastrointestinal disorders | Systematic Assessment | Perforation: medical intervention (nothing by mouth, antibiotics. Related to Endoscopic Procedure, |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Burbage, Principal Clinical Trial Manager | Boston Scientific | 7812544679 | andrea.burbage@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2023 | Mar 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2023 | Mar 31, 2025 | SAP_001.pdf |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| St Michael's Hospital | Toronto | Onterio | M5B 1W8 | Canada |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2X 0A9 | Canada |
| Shanghai Zhongshan Hospital | Shanghai | Xuhui District | 200031 | China |
| Prince of Wales Hospital The Chinese University of Hong Kong | Hong Kong | Shatin | Hong Kong |
| Asian Institute of Gastroenterology | Hyderabad | Telangana | 500082 | India |
| Showa University Koto Toyosu Hospital | Tokyo | Koto-Ku | 1358577 | Japan |
| von 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Up to 30 Days after the index clipping procedure |
|
|
|
| Primary | Number of Lesions With Defect Closures | Clinical success defined as defect closure | Posted | Count of Units | Lesions | Index Procedure | Lesions | Lesions |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Up to 30 Days after the Endocsopic clipping procedure |
|
|
|
| 1 |
| 240 |
| 14 |
| 240 |
| 0 |
| 240 |
|
| Death - Worsening sepsis | Gastrointestinal disorders | Systematic Assessment | Not Related to device or procedure |
|
| Aspiration | Gastrointestinal disorders | Systematic Assessment | Mild related to endoscopic procedure |
|
| Diverticular bleed - site unknown | Gastrointestinal disorders | Systematic Assessment | Moderate related to Endoscopic Procedure |
|
| GI Mucosal injury | Gastrointestinal disorders | Systematic Assessment | Moderate related to the procedure |
|
| Intrasubmucosal leak | Gastrointestinal disorders | Systematic Assessment | Moderate related to clipping procedure |
|
| Ischemia colitis | Gastrointestinal disorders | Systematic Assessment | Moderate related to Endoscopic Procedure |
|
| Left lower abdominal pain | Gastrointestinal disorders | Systematic Assessment | Moderate not related to clipping procedure or device |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Moderate related to Endoscopic Procedure |
|
| Ongoing lower GI bleeding | Gastrointestinal disorders | Systematic Assessment | Mild bleeding related to Endoscopic Procedure |
|
| Pneumoperitoneum | Gastrointestinal disorders | Systematic Assessment | Moderate related to Endoscopic Procedure |
|
| Post EMR lower GI Bleeding | Gastrointestinal disorders | Systematic Assessment | Mild bleeding related to Endoscopic Procedure |
|
| Post-Polypectomy Syndrome | Gastrointestinal disorders | Systematic Assessment | Moderate related to Endoscopic Procedure |
|
| Septic shock | Gastrointestinal disorders | Systematic Assessment | Moderate related to the Endoscopic Procedure, Clipping Procedure, Device and the mucosotomy opening |
|
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