RecruitingPhase 4NCT06054880

Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency

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

Sponsor

Prove pharm

Enrollment

116 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

Ureter Injury

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

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 Criteria9

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

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Interventions

DRUGIndigotindisulfonate sodium 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.

OTHERSaline injection 0.9%

Placebo