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Completed

NCT Number: NCT04228445

3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency

To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution for injection provides a visualization advantage compared to saline 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 3

Primary location

Adult and Pediatric Urology

Omaha, Nebraska, 68114, United States

About this study

This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of two doses (2.5 mL and 5.0 mL) of 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from approximately 10 study centers in the United States.

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 written, IRB approved, informed consent form.
  • Subjects scheduled for urological or gynecological surgical procedures in which the patency of the ureter must be assessed by the surgeon during the procedure

Exclusion criteria

  • Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
  • Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
  • 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

3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 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.

Saline spray

Drug

Placebo

Primary outcomes

  1. Urine Jet Conspicuity Score

    Time frame: 10 minutes

    The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale.

    • = 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

Secondary outcomes

  1. Percentage of Responders

    Time frame: 10 Minutes

    A subject was a responder when there was ≥1-point improvement in the urine jet conspicuity scores following the indigo carmine versus saline treatment (indigo carmine - saline ≥1) and the conspicuity score following the indigo carmine treatment was 3, 4, or 5. The responder criteria were assessed separately for each ureter for each subject based on the blinded central reviewer's conspicuity score.

  2. Physician Satisfaction Agreement Scale

    Time frame: 10 Minutes

    After the completion of the procedure, the surgeon rated the experience of using indigo carmine for each subject using the 5-point PSAS, in which:

    "Compared to the use of saline treatment, my ability to assess ureteral patency was improved after the addition of indigo carmine."

    • = Strongly Agree
    • = Agree
    • = Neither Agree nor Disagree
    • = Disagree
    • = Strongly Disagree

    The surgeon was considered satisfied with the indigo carmine treatment if his/her rating was either a 1 (strongly agree) or a 2 (agree); otherwise, the surgeon was considered unsatisfied with the indigo carmine treatment.

  3. Time to Visualization

    Time frame: 10 Minutes

    Time to visualization (minutes) of blue color in the ureteral jets flow following indigo carmine treatment

Other outcomes

  1. Surgeon Urine Jet Conspicuity Score

    Time frame: 10 Minutes

    The urine jet conspicuity score provided by the surgeon as assessed by the following 5-point ordinal scale.

    • = 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

  2. Concordance of Conspicuity Scores

    Time frame: 10 Min

    Concordance of conspicuity scores between the surgeons' assessments and the blinded central reviewer assessments. If the difference between raters in conspicuity score was within ±1 (ie, the difference ranged from 1 to +1, inclusive), the scores were considered to agree.

    The urine jet conspicuity score as assessed by the following 5-point ordinal scale.

    • = 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

  3. Conspicuity Score Difference Between the Indigo Carmine High Dose and Indigo Carmine Low Dose by Central Review Process

    Time frame: 10 minutes

    Exploratory analysis of the urine jet conspicuity score difference between the indigo carmine high dose and indigo carmine low dose by central review Process

    The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale.

    • = 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

  4. Conspicuity Score Difference Between the Indigo Carmine High Dose and Indigo Carmine Low Dose as Assessed by Surgeons Who Were Blinded to the Dose of Indigo Carmine

    Time frame: 10 Minutes

    Exploratory analysis of conspicuity score difference between the indigo carmine high dose and indigo carmine low dose as assessed by surgeons who were blinded to the dose of indigo carmine

    The urine jet conspicuity score as assessed by the following 5-point ordinal scale.

    • = 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

Sponsors and collaborators

Lead sponsor

Prove pharm

Industry

Registry information

Official study title

An Open-Label Study of Two Different Doses of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution When Used as an Aid for Ureteral Patency

Acronym: UP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2020
Registry last updated
Nov 30, 2022

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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