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Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
RecruitingPhase 4
An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Indigotindisulfonate sodium 0.8% (drug)
- Saline injection 0.9% (other)
Sponsor: Prove pharm · Participants: 116 · Started: Oct 12, 2023
Contact the study team
- Michelle Boytim, Ph.D. · Phone: 610-850-7115
Official record on ClinicalTrials.gov — NCT06054880
Locations in the U.S.
| New York | Albany Medical Center, Albany |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.