Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Fluorescence System Survey
研究概览
简要总结
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
详细描述
This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a minimum of 18 years of age
- •Study participant is planning to proceed with surgery
- •Willing to provide informed consent
- •Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
- •Females of childbearing potential must have a negative pregnancy test at screening and during the study.
排除标准
- •Patient has had prior surgery at the intended surgical site.
- •Patient has abnormal cardiac rhythm not controlled by medication.
- •Patient has moderate to severe renal impairment.
- •Patient has a history of fluorescein allergy.
- •Patient has a history of drug-related anaphylactic.
- •Presence of a concurrent disease or condition that may interfere with study participation.
- •Presence or history of any condition that, in the view of the investigator, places the patient at high risk of treatment compliance.
- •Use of any Investigational Product or investigational medial device within 30 days prior to screening.
研究组 & 干预措施
Dose Defining
A dose defining phase for each surgical setting.
干预措施: Bevonescein (Drug)
Dose Expansion
A dose expansion phase for each surgical setting.
干预措施: Bevonescein (Drug)
结局指标
主要结局
Fluorescence System Survey
时间窗: 28 (+5 days)
To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.
次要结局
- To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings(28 (+5 days))