N/A
Completed N=240
MANTIS Endoscopic Clipping Study
Hemostasis · Perforation Colon · Feeding Tube Complication · Endoscopy
Source: ClinicalTrials.gov NCT05653843 ↗
Enrolled (actual)
240
Serious AEs
5.8%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Hemostasis of Active Bleeding — 239 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hemostasis of Active Bleeding |
239 | — |
| PRIMARY Number of Participants With Prophylactic Hemostasis |
164 | — |
| PRIMARY Number of Lesions With Defect Closures |
4 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
10 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05653843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.