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drugset / Trial / NCT06085183

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

NCT06085183 ↗

Phase 4 Recruiting 48 enrolled Prove pharm
RandomizedCrossoverQuadruple-blindDiagnostic

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.

Timeline

Start
2023-12-20
Primary completion
2026-06-30
Completion
2026-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject INDIGOTINDISULFONATE Small molecule 2.5 ml —
Subject INDIGOTINDISULFONATE Small molecule 5 ml —

Indications

ureteral disorder