An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Prove pharm
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Responders to Bludigo
研究概览
简要总结
This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo when used as an aid in the determination of ureteral patency.
详细描述
Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. Screening will occur within 30 days before study drug administration (Day of Surgery). After signing the informed consent, review of inclusion and exclusion criteria will be performed, the collection of concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between ≥ 18 and ≤ 85 years old
- •Subjects who signed a written IRB approved, informed consent form
- •Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure
排除标准
- •Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min (calculated using the MDRD formula and standardized by using individual's body surface area) or need for dialysis in the near future, or having only 1 kidney
- •Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes
- •Known history of drug or alcohol abuse within 6 months prior to the time of screening visit
- •Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases)
- •Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures
- •Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •Subjects with life expectancy < 6 months
- •Requirement for concomitant treatment that could bias primary evaluation.
- •Subjects who are pregnant or breast-feeding
研究组 & 干预措施
Saline
116 subjects treated with 5 ml of saline then crossover to treatment arm
干预措施: Saline injection 0.9% (Other)
High Dose
58 subjects randomly treated with 5 mL of drug
干预措施: Indigotindisulfonate sodium 0.8% (Drug)
High Dose
58 subjects randomly treated with 5 mL of drug
干预措施: Saline injection 0.9% (Other)
Low Dose
58 subjects randomly treated with 2.5 mL of drug
干预措施: Indigotindisulfonate sodium 0.8% (Drug)
Low Dose
58 subjects randomly treated with 2.5 mL of drug
干预措施: Saline injection 0.9% (Other)
结局指标
主要结局
Responders to Bludigo
时间窗: 10 Minutes post study drug administration
Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows: 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color A subject is considered a responder to Bludigo™ if there is \>=1 point improvement in the conspicuity score following the Bludigo™- treatment vs the saline treatment and the conspicuity score for the Bludigo™ treatment must be (3, 4, or 5). The responder criteria will be assessed separately for each ureter (left or right) from each reviewer.
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .
时间窗: 10 minutes post study drug administration
Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows: 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color Paired sample difference (Bludigo™-Saline) in conspicuity score (PSDCS). PSDCS will be calculated for each ureter (left or right) for each subject from each reviewer.
次要结局
- Incidence of adverse events and serious adverse events.(30 days post study drug administration)
- Changes in clinical safety laboratory values(30 days post study drug administration)
- Changes in vital signs post treatment(30 days post study drug administration)
- Changes in ECG post treatment(30 days post study drug administration)
- Changes in blood pressure by dose group and BMI (kg/m^2)(30 days post study drug administration)
- Changes in heart rate by dose group and BMI (kg/m^2)(30 days post study drug administration)
- Changes in pulse oximetry by dose group and BMI (kg/m^2)(30 days post study drug administration)
- Physician Satisfaction(10 Minutes post study drug administration)
- Time to visualization(10 minutes post study drug administration)