A Prospective, Observational Clinical Registry Study to Assess Safety and Performance of AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Teleflex
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- Evaluating the performance of AE05ML
研究概览
简要总结
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.
详细描述
The objective of this clinical registry study is to evaluate safety and performance of the Weck® Auto Endo5® 5 mm automatic endoscopic 35 cm applier device (Teleflex Incorporated, Morrisville, NC, USA - further referred to as AE05ML) for delivery of Hem-o-lok® Medium Large (ML) polymer clips for the purpose of vessel / tissue structure ligation in laparoscopic surgery. This is a prospective, observational, multi-center, clinical registry study. All subjects will undergo vessel / tissue structure ligation using AE05ML during their indicated laparoscopic procedure as per standard of care and institutional policy and procedure.
The primary objective is to evaluate the safety and performance of AE05ML for delivery of ML Hem-o-lok polymer clips for the purpose of vessel / tissue structure ligation in adult subjects during laparoscopic procedures.
Primary Endpoints
- Safety: Incidence of device related adverse events (AE)
- Performance: Success / Failure of polymer clip delivery attempts The secondary objectives are to evaluate device performance characteristics and operator reported feedback regarding their experience using the device for each case.
Secondary Endpoint
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Scheduled for a laparoscopic procedure in which AE05ML will be used for vessel / tissue structure ligation
- •Capable of providing informed consent for participation
排除标准
- •Imprisoned
- •Cognitively impaired and unable to provide informed consent
结局指标
主要结局
Evaluating the performance of AE05ML
时间窗: Duration of AE05ML used during laparoscopic procedure
The primary objective is to evaluate the performance (Success / Failure of polymer clip delivery attempts) of AE05ML for delivery of ML Hem-o-lok polymer clips for the purpose of vessel / tissue structure ligation in adult subjects during laparoscopic procedures.
Evaluating the safety of AE05ML
时间窗: Duration of AE05ML used during laparoscopic procedure
The primary objective is to evaluate the safety (Incidence of device related adverse events (AE)) of AE05ML for delivery of ML Hem-o-lok polymer clips for the purpose of vessel / tissue structure ligation in adult subjects during laparoscopic procedures.
次要结局
- Evaluating device performance characteristics(Duration of AE05ML used during laparoscopic procedure)
- Evaluating operator reported feedback(Duration of AE05ML used during laparoscopic procedure)