A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Li-Cor, Inc.
- 试验地点
- 2
- 主要终点
- Evaluation of ureter delineation using a Likert scale to measure ureter visualization
研究概览
简要总结
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).
详细描述
The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Provide written informed consent prior to the initiation of study procedures.
- •At least 18 years of age.
- •Consent to undergo minimally invasive, lower pelvic surgery.
排除标准
- •Unwilling or unable to provide informed consent.
- •Unwilling or unable to comply with the requirements of the protocol.
- •Females who are pregnant, lactating, or planning a pregnancy throughout the study.
- •Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery.
- •Have known allergies to D-mannitol and/or citric acid.
- •Participation in another clinical trial involving a drug in the past 12 weeks.
- •Any other condition that, in the investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy of the investigational product, or determined not a safe candidate for surgery based on standard of care for current medical condition.
研究组 & 干预措施
Nerindocianine for injection
One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery.
干预措施: Nerindocianine for injection (Drug)
结局指标
主要结局
Evaluation of ureter delineation using a Likert scale to measure ureter visualization
时间窗: Surgical procedure duration, estimated up to 5 hours
Evaluation of the pelvic ureter under WL and NIR illumination
次要结局
- Treatment-Emergent Adverse Events(30 +/- 5 days)
- Hourly time point scores concurrence with video review(Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours))