Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
NCT06054880

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

Led by Prove pharm · Updated on 2026-01-22

116

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects between 65 18 and 64 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
Not Eligible

You will not qualify if you...

  • Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min or need for dialysis soon, or having only 1 kidney
  • Subjects with known severe hypersensitivity reactions to Bludigo12 or other dyes, including contrast dyes
  • Known history of drug or alcohol abuse within 6 months prior to screening
  • Subjects with conditions or diseases that prevent safe participation, as decided by the Investigator
  • Unable to meet protocol requirements or uncooperative
  • Investigator, study staff, or relatives involved in the study
  • Subjects with life expectancy less than 6 months
  • Requirement for treatments that could bias study evaluation
  • Subjects who are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Albany Medical Center

Albany, New York, United States, 12008

Actively Recruiting

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Research Team

M

Michelle Boytim, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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