A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 8
- 主要终点
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible
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.
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.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subject is between the ages of 16 and 75, inclusive at time of consent.
- •Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
- •Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.
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 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
- •Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
- •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 (SGOT) ≥ 2.5 × ULN
- •Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
- •Planned use of CYTALUX™ (pafolacianine) for surgery
研究组 & 干预措施
Efficacy
Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode.
干预措施: IS-001 (Drug)
结局指标
主要结局
Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible
时间窗: 30 minutes
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection
Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.
时间窗: 10 minutes
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection
次要结局
- degree of concordance of ureter visualization within independent readers(45 minutes)
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(45 minutes)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode(45 minutes)
- concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(45 minutes)
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length(45 minutes)
- Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(45 minutes)
- Determine degree of concordance of ureter visualization between independent readers(45 minutes)
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length(10)
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length(30)
- Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(10 minutes)
- Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(30 minutes)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode(10 minutes)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode(30 minutes)
- concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(10 minutes)
- concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(30 minutes)
- Determine degree of concordance of ureter visualization between independent readers(10 minutes)
- Determine degree of concordance of ureter visualization between independent readers(30 minutes)
- degree of concordance of ureter visualization within independent readers(10 minutes)
- degree of concordance of ureter visualization within independent readers(30 minutes)