drugset / Trial / NCT06054880

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

NCT06054880 ↗

Phase 4 Recruiting 116 enrolled Prove pharm
RandomizedCrossoverQuadruple-blindDiagnostic

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.

Timeline

Start
2023-10-12
Primary completion
2026-01-31
Completion
2026-02-28

Drugs

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

Indications