Clinical trial NCT04228445: 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ureter Injury
Lead sponsor: Prove pharm
Sponsor class: INDUSTRY
First posted: 2020-01-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urine Jet Conspicuity Score
timeFrame: 10 minutes
Secondary outcomes:
measure: Percentage of Responders
timeFrame: 10 Minutes
measure: Physician Satisfaction Agreement Scale
timeFrame: 10 Minutes
measure: Time to Visualization
timeFrame: 10 Minutes
Other outcomes:
measure: Surgeon Urine Jet Conspicuity Score
timeFrame: 10 Minutes
measure: Concordance of Conspicuity Scores
timeFrame: 10 Min
measure: Conspicuity Score Difference Between the Indigo Carmine High Dose and Indigo Carmine Low Dose by Central Review Process
timeFrame: 10 minutes
measure: 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
timeFrame: 10 Minutes
Locations:
city: Omaha
country: United States
facility: Adult and Pediatric Urology
state: Nebraska
Study officials:
affiliation: Prove pharm
name: Todd Koch
role: STUDY_DIRECTOR
References: