Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency (NCT06054880) | Clinical Trial Compass
RecruitingPhase 4
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
United States116 participantsStarted 2023-10-12
Plain-language summary
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.
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 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 Bludigoâ„¢ 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
What they're measuring
1
Paired sample difference (Bludigoâ„¢-Saline) in urine jet conspicuity score .
Timeframe: 10 minutes post study drug administration
2
Responders to Bludigo
Timeframe: 10 Minutes post study drug administration