3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2021-06-03

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Ureter Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HIGH DOSE

48 subjects randomly treated with 5 mL of drug

Group Type EXPERIMENTAL

3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%

Intervention Type DRUG

Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

Saline spray

Intervention Type DRUG

Placebo

LOW DOSE

48 subjects randomly treated with 2.5 mL of drug

Group Type EXPERIMENTAL

3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%

Intervention Type DRUG

Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

Saline spray

Intervention Type DRUG

Placebo

Saline

96 subjects treated with 5 ml of saline than crossover to treatment arm

Group Type PLACEBO_COMPARATOR

Saline spray

Intervention Type DRUG

Placebo

Interventions

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3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%

Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

Intervention Type DRUG

Saline spray

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No