Recruiting

Indigotindisulfonate

Sponsor:

Prove pharm

Code:

NCT06054880

Conditions

Ureter Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Indigotindisulfonate sodium 0.8%

Saline injection 0.9%

Study Details

Brief 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.

Conditions

Ureter Injury

Study ID

NCT06054880

Start date

Oct 12, 2023

Status verified date

Jan, 2026

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

placebo comparator: Saline

116 subjects treated with 5 ml of saline then crossover to treatment arm

experimental: High Dose

58 subjects randomly treated with 5 mL of drug

experimental: Low Dose

58 subjects randomly treated with 2.5 mL of drug

Interventions

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.

Saline injection 0.9%

Placebo

Primary outcome measure

  • Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score . [ Time Frame: 10 minutes post study drug administration ]
  • Responders to Bludigo [ Time Frame: 10 Minutes post study drug administration ]

Central Contacts and Locations

Central contacts

Michelle Boytim, Ph.D.

610-850-7115michelle.boytim@provepharm.com

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12008

More Information

Sponsor

Prove pharm

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prove pharm on 2026-01-22.