A Phase 2 Multi-Center Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Evaluate ureter visualization by Independent Reader
研究概览
简要总结
This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
详细描述
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between the ages of 18 and 75, inclusive
- •Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging
排除标准
- •Subject is pregnant or nursing
- •Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Subject has any of the following screening laboratory values:
- •eGFR < 60 mL/min/1.73 m^2
- •Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
- •Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
- •Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
- •Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
- •Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.
研究组 & 干预措施
Single Arm
Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections
干预措施: IS-001 (Drug)
结局指标
主要结局
Evaluate ureter visualization by Independent Reader
时间窗: 45 minutes after second IS-001 injection during surgery
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible
次要结局
- Evaluate fluorescent intensity of ureter by signal to background analysis(45 minutes after second IS-001 injection during surgery)
- Incidence of abnormal blood work in tests results(14 days post surgery)
- Incidence of abnormal urinalysis results(14 days post surgery)
- Evaluate ureter visualization by Intra-operative surgeon(45 minutes after second IS-001 injection during surgery)
- Safety 12-Lead EKG Change from Baseline(6 hours after first IS-001 injection post surgery)
- Safety Adverse Events Monitoring(14 days post surgery)
- Ureter Delineation Efficacy as Length of Line Drawn(45 minutes after second IS-001 injection during surgery)