MANTIS Endoscopic Clipping Study

Study Overview
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Brief Summary
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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
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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

Official Title
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MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:

Conditions
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Hemostasis, Perforation Colon, Feeding Tube Complication, Endoscopy

Intervention / Treatment
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* Device: Endoscopic clip placement in the gastrointestinal tract.


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endoscopic clip placement in the gastrointestinal tract.|The placement of a mechanical endoscopic clip in the gastrointestinal tract.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis of active bleeding | Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure | Procedure | 
| 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 | 30 Days | 
| Defect closure | Clinical success defined as defect closure | Procedure | 
| Affixing Jejunal Feeding tubes | Clinical success defined as affixing Jejunal Feeding tubes to the wall of the small bowel | Procedure | 
| Endoscopic Marking | Clinical success defined as endoscopic Marking | Procedure | 
| Resolution of the indication for clip placement | Clinical success defined as ability to complete desired indication of clip for other usage | Procedure | 
| Serious Adverse Events | Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clip deployment | Incidents of success at placement defined as ability to deploy the endoscopic clips in satisfactory position | Procedure | 
| Closure | Incidents of ability to approximate defect edges for secured closure. | Procedure | 
| Delayed bleeding | Incidents of post procedural bleeding, defined as a severe bleeding event that required hospitalization, a blood transfusion (>5 units), or another invasive intervention (angiographic or surgery) | 30 Days | 
| Active bleeding hemostasis | Rate of patients requiring additional modalities of hemostasis. Report of hemostasis of active bleeding 7 days after the index study procedure, defined as ability to stop the active bleed at the time of the study procedure and/or with additional clipping procedures to provide hemostasis of continued or recurrent bleeding within 7 days of the index study procedure | 7 Days |