Open Label, Single Center, Randomized Study Evaluating the Feasibility of the Ultravision™ Visual Field Clearing System in Low Pressure Laparoscopic Cholecystectomy Compared To AirsealL® IFS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of Visualization
研究概览
简要总结
This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.
详细描述
The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of lower pneumoperitoneal pressures whilst maintaining an adequate visual field throughout the procedure with low demand for CO2 replenishment to maintain pneumoperitoneal pressure. Comparisons in terms of surgical field visualization, procedure times, and CO2 consumption will be conducted in order to determine whether or not any clinical benefits are derived from the use of the Ultravision™ System compared to the Airseal® iFS. Low pressure laparoscopy for this study is set at 10mmHg. This is a prospective, open-label, randomized controlled study. The study will include two study arms. Patients undergoing laparoscopic cholecystectomy will be randomized to either "Ultravision" (study arm 1) or Airseal® iFS (study arm 2). Both groups will conduct the procedure at 10mmHg, considered to be low pressure/low impact laparoscopic surgery. The study will enroll 30 patients, 15 per group. Both devices are being used according to their cleared label claims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Is 18 years or older
- •Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
- •Agrees to attend all follow-up assessments
- •Is indicated for elective laparoscopic cholecystectomy
排除标准
- •Existing comorbidities that would contraindicate them for laparoscopic surgery
- •Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
- •Body Mass Index > 50
- •Be pregnant (if female)
- •Has a condition of unrelated chronic pain requiring medication
结局指标
主要结局
Quality of Visualization
时间窗: Measured from camera insertion through removal
The quality of visualization in the laparoscopic field
Carbon Dioxide Utilization
时间窗: Measured from Veress needle insertion to just prior to gall bladder removal
The volume measured in Liters of Carbon Dioxide consumed during the procedure
次要结局
- Diathermy Power Setting(Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy)
- Laparoscope cleaning(Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy)
- Trocar Venting(Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy)
- Procedure time for Diathermy use(Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy)
- Procedure Time(Measured from the insertion of the camera to the time of closure)
- End tidal CO2 Volume(Measured at Veress needle insertion and just prior to gall bladder removal)
- Case Complexity(Immediately post-procedure)
- Pneumoperitoneum Pressure(Starting pneumoperitoneum pressure at the time of camera trocar insertion, record the maximum pressure that occurred during the procedure)
- Pain Assessment(Pre-procedure and 1 to 7 days post procedure)
- Pain Medications(1 to 7 days post procedure)