3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Pa… (NCT04228445) | Clinical Trial Compass
CompletedPhase 3
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
United States121 participantsStarted 2020-02-13
Plain-language summary
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
Who can participate
Age range18 Years – 85 Years
SexALL
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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.