靛蓝二磺酸钠注射液（USP）有助于确定输尿管通畅性
一项开放标签、随机、多中心研究，旨在评估两种不同剂量的 Bludigo™（靛蓝二磺酸钠注射液，USP）0.8% 用于辅助确定输尿管通畅时的安全性、有效性和医生满意度
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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New York
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Albany、New York、美国、12008
- Albany Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Saline
116 subjects treated with 5 ml of saline then crossover to treatment arm |
Placebo |
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实验性的：High Dose
58 subjects randomly treated with 5 mL of drug |
Placebo Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
其他名称：
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实验性的：Low Dose
58 subjects randomly treated with 2.5 mL of drug |
Placebo Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .
大体时间：10 minutes post study drug administration
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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:
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. |
10 minutes post study drug administration
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Responders to Bludigo
大体时间：10 Minutes post study drug administration
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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:
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. |
10 Minutes post study drug administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of adverse events and serious adverse events.
大体时间：30 days post study drug administration
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Percentage of patients in each treatment group who experience an adverse event post treatment |
30 days post study drug administration
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Changes in clinical safety laboratory values
大体时间：30 days post study drug administration
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Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment |
30 days post study drug administration
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Changes in vital signs post treatment
大体时间：30 days post study drug administration
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Proportion of subjects with clinically important changes in vital signs after treatment |
30 days post study drug administration
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Changes in ECG post treatment
大体时间：30 days post study drug administration
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Proportion of subjects with clinically important changes in ECGs after treatment |
30 days post study drug administration
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Changes in blood pressure by dose group and BMI (kg/m^2)
大体时间：30 days post study drug administration
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Comparison of post treatment changes in blood pressure by dose group and BMI (kg/m^2) |
30 days post study drug administration
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Changes in heart rate by dose group and BMI (kg/m^2)
大体时间：30 days post study drug administration
|
Comparison of post treatment changes in heart rate by dose group and BMI (kg/m^2) |
30 days post study drug administration
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Changes in pulse oximetry by dose group and BMI (kg/m^2)
大体时间：30 days post study drug administration
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Comparison of post treatment changes in pulse oximetry by dose group and BMI (kg/m^2) |
30 days post study drug administration
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Physician Satisfaction
大体时间：10 Minutes post study drug administration
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To determine physicians' overall satisfaction with the Bludigo™ treatment by assessing the proportion of surgeons who agree using the 5-point Physician Satisfaction Agreement Scale (PSAS) with the statement: "Compared to the saline treatment, my ability to assess ureter patency was improved after the addition of Bludigo™."
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10 Minutes post study drug administration
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Time to visualization
大体时间：10 minutes post study drug administration
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To describe the time to visualization (TTV) of blue color in the ureteral jets flow following Bludigo™ treatment |
10 minutes post study drug administration
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合作者和调查者
赞助
调查人员
- 研究主任：Michelle Boytim, Ph.D.、Provepharm SAS
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PVP-22IC04
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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