SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Outcome 1
研究概览
简要总结
This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images.
The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Subject is 18 years of age or older
- •Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent
- •Subject provides informed consent and signs an approved informed consent document for the study
- •Subject is willing to comply with the protocol and study visit schedule
排除标准
- •Subject is pregnant or lactating
- •Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes
- •Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease
- •Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
结局指标
主要结局
Outcome 1
时间窗: Intra-op visit
To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy
次要结局
- Outcome 2(Intra-op visit)