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

NCT04228445 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: PVP-19IC01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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

Conditions

Ureter Injury

Outcome Measures

Primary Outcomes (1)

• 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. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color

  10 minutes

Secondary Outcomes (3)

• Percentage of Responders

  10 Minutes

• Physician Satisfaction Agreement Scale

  10 Minutes

• Time to Visualization

  10 Minutes

Other Outcomes (4)

• Surgeon Urine Jet Conspicuity Score

  10 Minutes

• Concordance of Conspicuity Scores

  10 Min

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

  10 minutes

Study Arms (3)

HIGH DOSE

EXPERIMENTAL

48 subjects randomly treated with 5 mL of drug

Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Drug: Saline spray

LOW DOSE

EXPERIMENTAL

48 subjects randomly treated with 2.5 mL of drug

Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Drug: Saline spray

Saline

PLACEBO COMPARATOR

96 subjects treated with 5 ml of saline than crossover to treatment arm

Drug: Saline spray

Interventions

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.

HIGH DOSE; LOW DOSE

Saline spray DRUG

Placebo

HIGH DOSE; LOW DOSE; Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prove pharm: lead

Study Sites (1)

Adult and Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

Results Point of Contact

• Title: Senior Director of Clinical Operations
• Organization: Provepharm, Inc.

todd.koch@provepharm.com

6106018605

Study Officials

• Todd Koch

  Prove pharm

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 14, 2020
• Study Start: February 13, 2020
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)