Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
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
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
