Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI): a Multicentre Post-market Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Device safety
研究概览
简要总结
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
详细描述
The study will observe patients undergoing bowel resection and cholecystectomy surgeries to determine if HyperSnap Surgical System (HSS1), as a primary visualisation tool, functions safely and capably as a laparoscopic imager. In addition, we will see if it subjectively improves the identification of critical anatomical structures. In addition, the study will secondarily assess how StO2 information may be included in the surgical workflow and how surgeons may react to this additional information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
- •Adult patients aged 18 years and over
- •Common bile duct diameter < 8mm as assessed using ultrasound
- •Patients able to provide written informed consent
- •B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
- •Adult patients aged 18 years and over
- •Patients who are scheduled for elective laparoscopic colon cancer resection
- •Patients able to provide written informed consent
排除标准
- •A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
- •Patients under 18 years of age
- •Patients with a history of previous abdominal surgery and multiply scarred abdomen
- •Common bile duct diameter ≥ 8mm as assessed using ultrasound
- •Patients unable to provide written informed consent
- •Patients who are pregnant
- •B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
- •Patients under 18 years of age
- •Patients with a history of previous abdominal surgery and multiply scarred abdomen
- •Patients unable to provide written informed consent
- •Patients undergoing emergency surgery
- •Patients who are pregnant
结局指标
主要结局
Device safety
时间窗: From enrollment to end of follow up (30 days)
To demonstrate that under normal conditions of use, the performance characteristics of the device are those intended, enabling laparoscopic abdominal surgery to be safely performed using the UKCA-marked medical device (HSS1) as the primary surgical visualisation system.
次要结局
- Technological performance(Duration of surgery)
- Utility and usability of tissue oxygenation saturation maps in bowel surgery(Duration of surgery)
- Utility and usability of tissue oxygenation saturation maps in cholecystectomy(Duration of surgery)
- Human factors analysis on use of HSS1(Duration of surgery)