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

Part of paid clinical trials in Albany, New York.

Sponsor
Prove pharm
Study ID
NCT06054880
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ureter Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Indigotindisulfonate sodium 0.8% — DRUG
    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% — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Oct 12, 2023
Status verified
Jan 2026
Primary completion
Jan 31, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Albany Medical CenterAlbanyNew York12008
Mark White, MD

Find similar trials in Albany, NY

By research site
Albany Medical Center· Albany, NY

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