Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic cholelithiasis
- •Age 18-60
- •Able to sign an informed consent
排除标准
- •ASA 3 or more
- •Acute cholecystitis
- •Choledocholithiasis
- •Coagulation disorders
- •Patients on blood thinners
- •Use of Steroids
研究组 & 干预措施
A
Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.
干预措施: Gallbladder retraction (Device)
结局指标
主要结局
Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument.
时间窗: 1 year
次要结局
- No adverse effects related directly to the use of the Endograb retractor.(1 year)