A Single Arm, Prospective, Open Label, Multicenter Study Assessing Efficacy and Utility of the Visualization of Intraoperative Speckle Imaging for Real-Time Assessment Of PerfusioN in Left Sided Colectomy With ActivSight
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- White Light Imaging
研究概览
简要总结
The goal of this clinical trial is to evaluate and compare the clinical utility of Indocyanine Green (ICG) fluorescence angiography and Laser Speckle
Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during colorectal resection in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:
What is the clinical utility of Indocyanine Green (ICG) fluorescence angiography compared to Laser Speckle Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during colorectal resection?
Participants will undergo a laparoscopic/robotic (where an extracorporeal anastomosis formed)/open colectomy with ligation of the inferior mesenteric artery and a planned anastomosis of 5cm to 15 cm from the anal verge where both ICG and LSCI modalities will be applied to all subjects.
详细描述
This is a single-arm, prospective, non-randomized, within-patient crossover study designed to evaluate the effectiveness of Laser Speckle Contrast Imaging (LSCI) using ActivSight™ as an advanced intraoperative visualization tool for assessing tissue perfusion in left-sided colectomies. The standard of care-Indocyanine Green (ICG) fluorescence angiography-will be used concurrently to compare perfusion assessment capabilities between the two imaging modalities. The study will also explore the potential of LSCI in reducing the incidence of anastomotic leak (AL) and related postoperative complications.
Participants will undergo left-sided colorectal resection (high or low) with planned anastomosis 5 - 15cm from the anal verge using a circular stapler. The procedure may be performed using either a laparoscopic, open or robotic approach with standard surgical equipment based on the surgeon's standard technique.
- High anterior resection is defined as resection and anastomosis above the peritoneal reflection.
- Low anterior resection refers to resection and anastomosis below the peritoneal reflection.
The specific operative technique, including the method of stapled will be at the discretion of the operating surgeon. The level of colonic transection, formation of an anastomosis, and any defunctioning stoma will be performed in accordance with the surgeon's standard clinical practice
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
- •Subject is scheduled for laparoscopic/robotic (where an extracorporeal anastomosis formed)/open colectomy with ligation of the inferior mesenteric artery and a planned anastomosis of 5cm to 15 cm from the anal verge using a circular stapler only
- •A negative pregnancy test for women of childbearing potential prior to surgery
- •Participants who are able and willing to complete required study procedures
- •Participants who are able and willing to provide a signed and dated ICF
排除标准
- •Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
- •Subject who receives hand sewn anastomosis
- •Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the study procedure
- •Subject has a previous history of radiation therapy
- •Subject that has Hinchey 3 and 4 diverticulitis
- •Subject is a pregnant or lactating female
研究组 & 干预措施
ICG & LSCI
Intervention is the Activsight Intraoperative Imaging System. Both imaging modalities, ICG and LSCI, will be utilized during surgery for all subjects.
干预措施: ActivSight™ Intraoperative Imaging System (Device)
结局指标
主要结局
White Light Imaging
时间窗: during surgery
Determine optimal proximal bowel transection site using white light imaging or naked eye, marking with clip, bovie, pen, etc.
ICG Uptake
时间窗: during surgery
Determine the optimal proximal bowel transection site using at initial uptake of ICG prior to division of bowel and determine diffusion of ICG at 30 seconds, 60 seconds and 90 seconds after initial uptake.
LSCI-based Perfusion
时间窗: during surgery
Determine the optimal proximal bowel transection site using LSCI-based perfusion imaging prior to division of bowel.
次要结局
- Tissue Perfusion(during surgery)
- Diversion(during surgery)
- Surgical Decision Making(during surgery)
- Anastomotic Leak Rate(from surgery to end of follow up period/30 days post surgery)