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RECRUITING
NCT06085183
PHASE4

Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment

Sponsor: Prove pharm

View on ClinicalTrials.gov

Summary

This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.

Official title: An Open-Label, Randomized, Parallel Group Study to Investigate the Influence of Renal Impairment on the Efficacy and Safety of Two Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-12-20

Completion Date

2026-07-31

Last Updated

2026-01-22

Healthy Volunteers

No

Conditions

Interventions

OTHER

Saline Injection 0.9%

Placebo

DRUG

Indigotindisulfonate 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.

Locations (1)

Albany Medical Center

Albany, New York, United States