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NCT Number: NCT06054880

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

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.

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Key information

Conditions

Ureter Injury

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albany Medical Center

Albany, New York, 12008, United States

Location status: Recruiting

Location contact

Mark White, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bludigo

Saline Injection 0.9%

Other

Placebo

Primary outcomes

  1. Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .

    Time frame: 10 minutes post study drug administration

    Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows:

    • = No jet observed
    • = Weak jet, little color contrast
    • = Color contrast or significant jet flow
    • = Strong jet flow with good color contrast
    • = Strong jet flow with striking contrast in color

    Paired sample difference (Bludigo™-Saline) in conspicuity score (PSDCS). PSDCS will be calculated for each ureter (left or right) for each subject from each reviewer.

  2. Responders to Bludigo

    Time frame: 10 Minutes post study drug administration

    Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows:

    • = No jet observed
    • = Weak jet, little color contrast
    • = Color contrast or significant jet flow
    • = Strong jet flow with good color contrast
    • = Strong jet flow with striking contrast in color

    A subject is considered a responder to Bludigo™ if there is >=1 point improvement in the conspicuity score following the Bludigo™- treatment vs the saline treatment and the conspicuity score for the Bludigo™ treatment must be (3, 4, or 5). The responder criteria will be assessed separately for each ureter (left or right) from each reviewer.

Secondary outcomes

  1. Incidence of adverse events and serious adverse events.

    Time frame: 30 days post study drug administration

    Percentage of patients in each treatment group who experience an adverse event post treatment

  2. Changes in clinical safety laboratory values

    Time frame: 30 days post study drug administration

    Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment

  3. Changes in vital signs post treatment

    Time frame: 30 days post study drug administration

    Proportion of subjects with clinically important changes in vital signs after treatment

  4. Changes in ECG post treatment

    Time frame: 30 days post study drug administration

    Proportion of subjects with clinically important changes in ECGs after treatment

  5. Changes in blood pressure by dose group and BMI (kg/m^2)

    Time frame: 30 days post study drug administration

    Comparison of post treatment changes in blood pressure by dose group and BMI (kg/m^2)

  6. Changes in heart rate by dose group and BMI (kg/m^2)

    Time frame: 30 days post study drug administration

    Comparison of post treatment changes in heart rate by dose group and BMI (kg/m^2)

  7. Changes in pulse oximetry by dose group and BMI (kg/m^2)

    Time frame: 30 days post study drug administration

    Comparison of post treatment changes in pulse oximetry by dose group and BMI (kg/m^2)

  8. Physician Satisfaction

    Time frame: 10 Minutes post study drug administration

    To determine physicians' overall satisfaction with the Bludigo™ treatment by assessing the proportion of surgeons who agree using the 5-point Physician Satisfaction Agreement Scale (PSAS) with the statement:

    "Compared to the saline treatment, my ability to assess ureter patency was improved after the addition of Bludigo™."

    • = Strongly Agree
    • = Agree
    • = Neither Agree nor Disagree
    • = Disagree
    • = Strongly Disagree A surgeon's evaluation is considered satisfactory if the rating is either a 1 (strongly agree) or 2 (agree).

  9. Time to visualization

    Time frame: 10 minutes post study drug administration

    To describe the time to visualization (TTV) of blue color in the ureteral jets flow following Bludigo™ treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Boytim, Ph.D.

CONTACT

[email protected]

610-850-7115

Sponsors and collaborators

Lead sponsor

Prove pharm

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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