MANTIS Endoscopic Clipping Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-08-07

Brief Summary

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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 MANTIS™ including but not limited to hemostasis, closure, anchoring and marking.

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Detailed Description

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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

Conditions

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Hemostasis Perforation Colon Feeding Tube Complication Endoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic clip placement in the gastrointestinal tract.

The placement of a mechanical endoscopic clip in the gastrointestinal tract.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No