Prospective, Randomized Comparison of the Use of FloShield Air System Versus Clearify Visualization System (D-HELP) During Laparoscopic Surgery to Evaluate the Operative Interruption for Lens Cleaning
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- number of Laparoscope removals during surgery
研究概览
简要总结
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.
详细描述
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery. The study will be randomized across two groups, one group will evaluate laparoscopic lens cleaning with D-HELP during laparoscopic surgery and the second group will evaluate laparoscopic lens cleaning using the FloShield Air System during laparoscopic surgery. Each surgery will be captured on video. Study parameters will be evaluated through review of each video by an independent evaluator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Female or Male;
- •18 years of age or older;
- •Patient scheduled for gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery under the care of the study investigator;
- •Suitable candidate for surgery
排除标准
- •Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator);
- •Use of Surgiquest AirSeal®;
- •Use of humidified insufflation
结局指标
主要结局
number of Laparoscope removals during surgery
时间窗: 0.5hr - 6hr
The performance evaluations of the FloShield Air System will be based the difference between the cohorts on the number of scope removals per surgery.
次要结局
未报告次要终点