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

Part of paid clinical trials in Albany, New York.

Sponsor
Prove pharm
Study ID
NCT06085183
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

  • Saline Injection 0.9% — OTHER
    Placebo
  • 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.

Study Details

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.

Key Dates

Start date
Dec 20, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Placebo Comparator: Saline
    48 subjects treated with 5 ml of saline then crossover to treatment arm
  • Experimental: High Dose
    24 subjects randomly treated with 5 mL of drug
  • Experimental: Low Dose
    24 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 to 15 minutes post study drug administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Albany Medical CenterAlbanyNew York12008
Mark D White, MD
[email protected]
518-262-8579

Find similar trials in Albany, NY

By research site
Albany Medical Center· Albany, NY

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