Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency

NCT06054880 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PVP-22IC04
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo when used as an aid in the determination of ureteral patency.

Conditions

Ureter Injury

Outcome Measures

Primary Outcomes (2)

• Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .

  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: 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 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.

  10 minutes post study drug administration

• Responders to Bludigo

  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: 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 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.

  10 Minutes post study drug administration

Secondary Outcomes (9)

• Incidence of adverse events and serious adverse events.

  30 days post study drug administration

• Changes in clinical safety laboratory values

  30 days post study drug administration

• Changes in vital signs post treatment

  30 days post study drug administration

• Changes in ECG post treatment

  30 days post study drug administration

• Changes in blood pressure by dose group and BMI (kg/m^2)

  30 days post study drug administration

Study Arms (3)

Saline

PLACEBO COMPARATOR

116 subjects treated with 5 ml of saline then crossover to treatment arm

Other: Saline injection 0.9%

High Dose

EXPERIMENTAL

58 subjects randomly treated with 5 mL of drug

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

Low Dose

EXPERIMENTAL

58 subjects randomly treated with 2.5 mL of drug

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

Interventions

Indigotindisulfonate sodium 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.

Also known as: Bludigo

High Dose; Low Dose

Saline injection 0.9% OTHER

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prove pharm: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12008, United States

RECRUITING

Study Officials

• Michelle Boytim, Ph.D.

  Provepharm SAS

  STUDY DIRECTOR

Central Study Contacts

Michelle Boytim, Ph.D.

CONTACT

610-850-7115; michelle.boytim@provepharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 26, 2023
• Study Start: October 12, 2023
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)