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An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ (Indigotindisulfonate Sodium Injection, USP) 0.8% When Used as an Aid in the Determination of Ureteral Patency.

An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ (Indigotindisulfonate Sodium Injection, USP) 0.8% When Used as an Aid in the Determination of Ureteral Patency.

  • Clinical Trial Information

    Trial Contact: Britton, David

    Trial Phone: 321.841.2684

  • IRB No: 20232322

    Protocol Abbrev: PVP-22IC04

    Principal Investigator: Lucas Wiegand, MD

    Phase: Drug: Phase IV

    Age Group: Adult

    Secondary Protocol No: PVP-22IC04

    Treatment: Drug: Indigotindisulfonate sodium 0.8% Other: Saline injection 0.9%

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT06054880

  • Objective

    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.


    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 Outcome Measures :
    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

    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

    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

    Changes in ECG post treatment [ Time Frame: 30 days post study drug administration ]
    Proportion of subjects with clinically important changes in ECGs after treatment

    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)

    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)

    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)

    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).

    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

  • Key Eligibility

    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