MANTIS Clip Study: A Prospective, Multi-Center, All-Comer MANTIS Endoscopic Clipping Study:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 10
- 主要终点
- Number of Participants With Prophylactic Hemostasis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants With Prophylactic Hemostasis
时间窗: Up to 30 Days after the index clipping procedure
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
Number of Participants With Hemostasis of Active Bleeding
时间窗: Index Procedure
Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Number of Lesions With Defect Closures
时间窗: Index Procedure
Clinical success defined as defect closure
Number of Participants With Serious Adverse Events
时间窗: Up to 30 Days after the Endocsopic clipping procedure
Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure
次要结局
未报告次要终点