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

Ureter Injury Clinical Trial

— UP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228445
• Other study ID #: PVP-19IC01
• Status: Completed
• Phase: Phase 3
• Start date: February 13, 2020
• Est. completion date: June 3, 2021

Study information

• Verified date: November 2022
• Source: Prove pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ureter Injury

Intervention

Drug:
• 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 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.
• Saline spray
Placebo

Locations

Country	Name	City	State
United States	Adult and Pediatric Urology	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Prove pharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgeon Urine Jet Conspicuity Score	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	10 Minutes
Other	Concordance of Conspicuity Scores	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	10 Min
Other	Conspicuity Score Difference Between the Indigo Carmine High Dose and Indigo Carmine Low Dose by Central Review Process	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	10 minutes
Other	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	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	10 Minutes
Primary	Urine Jet Conspicuity Score	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	10 minutes
Secondary	Percentage of Responders	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.	10 Minutes
Secondary	Physician Satisfaction Agreement Scale	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.	10 Minutes
Secondary	Time to Visualization	Time to visualization (minutes) of blue color in the ureteral jets flow following indigo carmine treatment	10 Minutes