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

Official title

An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency

Overview

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.

Detailed description

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.

Interventions

• Drug 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.
• Other Saline injection 0.9%
  Placebo

Primary outcome measures

• 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]

Secondary outcome measures (9)

• Incidence of adverse events and serious adverse events. [Time frame: 30 days post study drug administration]
• Changes in clinical safety laboratory values [Time frame: 30 days post study drug administration]
• Changes in vital signs post treatment [Time frame: 30 days post study drug administration]
• Changes in ECG post treatment [Time frame: 30 days post study drug administration]
• Changes in blood pressure by dose group and BMI (kg/m^2) [Time frame: 30 days post study drug administration]
• Changes in heart rate by dose group and BMI (kg/m^2) [Time frame: 30 days post study drug administration]
• Changes in pulse oximetry by dose group and BMI (kg/m^2) [Time frame: 30 days post study drug administration]
• Physician Satisfaction [Time frame: 10 Minutes post study drug administration]
• Time to visualization [Time frame: 10 minutes post study drug administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Albany Medical Center — Albany

Identifiers

NCT: NCT06054880 · PVP-22IC04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗