A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Gynecological 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
- 94
- 试验地点
- 3
- 主要终点
- Evaluate fluorescent intensity of ureter by signal to background analysis
研究概览
简要总结
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
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 efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subject is between the ages of 18 and 75, inclusive
- •Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging
- •Subject is willing and able to provide informed consent
- •Subject is considered capable of complying with study procedures
排除标准
- •Subject is pregnant or nursing
- •Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Subject is already enrolled in another investigational study
- •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
研究组 & 干预措施
Dose-escalation
Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined.
干预措施: IS-001 (Drug)
Optimal dose-characterization
Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures.
干预措施: IS-001 (Drug)
Optimal dose-characterization
Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures.
干预措施: No treatment (Drug)
结局指标
主要结局
Evaluate fluorescent intensity of ureter by signal to background analysis
时间窗: 60 minutes
Fluorescent intensity of ureter evaluated as signal to background
次要结局
- Incidence of abnormal blood work in tests results(14 days)
- Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels(0, 1-2 hours and 2-3 hours)
- Pharmacokinetics Apparent Volume of Distribution (Vz)(0, 1-2 hours and 2-3 hours)
- Ureter Identification Efficacy on a Nominal Scale(60 minutes)
- Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf)(0, 1-2 hours and 2-3 hours)
- Pharmacokinetics Terminal Elimination Half-life (t1/2)(0, 1-2 hours and 2-3 hours)
- Ureter Delineation Efficacy as Length of Line Drawn(60 minutes)
- Safety 12-Lead EKG Change from Baseline(6 hours)
- Safety Adverse Events Monitoring(14 days)
- Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast)(0, 1-2 hours and 2-3 hours)
- Pharmacokinetics Drug Plasma Clearance (CL)(0, 1-2 hours and 2-3 hours)
- Incidence of abnormal urinalysis results(14 days)
- Ureter Delineation Efficacy as Length of Line Drawn in Millimeters(10 minutes)
- Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale(60 minutes post-dose)
- Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale(60 minutes post-dose)