An Open-Label Study of Two Different Doses of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution When Used as an Aid for Ureteral Patency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Prove pharm
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Urine Jet Conspicuity Score
研究概览
简要总结
To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution for injection provides a visualization advantage compared to saline when used as an aid in the determination of ureteral patency
详细描述
This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of two doses (2.5 mL and 5.0 mL) of 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from approximately 10 study centers in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 written, IRB approved, informed consent form.
- •Subjects scheduled for urological or gynecological surgical procedures in which the patency of the ureter must be assessed by the surgeon during the procedure
排除标准
- •Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
- •Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
- •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
HIGH DOSE
48 subjects randomly treated with 5 mL of drug
干预措施: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% (Drug)
HIGH DOSE
48 subjects randomly treated with 5 mL of drug
干预措施: Saline spray (Drug)
LOW DOSE
48 subjects randomly treated with 2.5 mL of drug
干预措施: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% (Drug)
LOW DOSE
48 subjects randomly treated with 2.5 mL of drug
干预措施: Saline spray (Drug)
Saline
96 subjects treated with 5 ml of saline than crossover to treatment arm
干预措施: Saline spray (Drug)
结局指标
主要结局
Urine Jet Conspicuity Score
时间窗: 10 minutes
The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale. 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
次要结局
- Percentage of Responders(10 Minutes)
- Physician Satisfaction Agreement Scale(10 Minutes)
- Time to Visualization(10 Minutes)