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

Last updated: November 14, 2024
Sponsor: Prove pharm
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Saline injection 0.9%

Indigotindisulfonate sodium 0.8%

Clinical Study ID

NCT06054880
PVP-22IC04
  • Ages 18-85
  • All Genders

Study 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™ (indigotindisulfonate Sodium Injection, USP) 0.8% when used as an aid in the determination of ureteral patency.

Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. Screening will occur within 30 days before study drug administration (Day of Surgery). After signing the informed consent, review of inclusion and exclusion criteria will be performed, the collection of concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.

On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose.

All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.

Eligibility Criteria

Inclusion

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 mustbe assessed by cystoscopy following the procedure

Exclusion

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 bodysurface 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 ofscreening visit

  • Subjects, as assessed by the Investigator, with conditions/concomitant diseasesprecluding their safe participation in this study (e.g. major systemic diseases)

  • Unable to meet specific protocol requirements (e.g., scheduled visits) or subject isuncooperative or has a condition that could lead to non-compliance with the studyprocedures

  • Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist,study coordinator, other staff or relative thereof directly involved in the conductof 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

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Saline injection 0.9%
Phase: 4
Study Start date:
October 12, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Albany Medical Center

    Albany, New York 12008
    United States

    Active - Recruiting

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