Ureter InjuryPhase 3NCT06448143
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients
A Phase 3 study testing Indigotindisulfonate sodium 0.8% injection in people with Ureter Injury, run by Prove pharm.
Trial summary
This is an open-label, multicenter study to evaluate the safety, pharmacokinetics, and conspicuity of a weight-based Bludigo® dose (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL and not to exceed 2.5 mL) when used as an aid in the determination of ureteral patency in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Ureter Injury
- What is being tested?
- Indigotindisulfonate sodium 0.8% injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- I01. Patients from birth to < 17 years
- I02. Patients whose Parents or Legal Authorized Representative (LAR) have signed a written, IRB approved, informed consent form (ICF) and applicable assent obtained.
- I03. Patients scheduled for urological or gynecological surgical procedures in which the patency of the ureters must be assessed by the surgeon during the surgery.
Who cannot join
- E01. For patients ≥ 1 year of age, Stage 5 Chronic Kidney Failure (defined as an eGFR (estimated glomerular filtration rate) ≤ 15mL/min/1.73 m2). (Calculated using the revised "Bedside Schwartz" equation (Schwartz et al. 2009) ). The revised "Bedside Schwartz" for eGFR is calculated as follows. eGFR (mL/min/1.73m2) = 0.413 height/Scr, where height is baseline height measured in cm and Scr is baseline serum creatine measured in mg/dL;
- For patients less than 1 year of age, measured serum creatinine greater than 1.5-times the upper limit of normal (>97.5 percentile) based on the reference table in Boer et al., 2010.
- E02. Patients weighing less than 5 kgs.
- E03. Patients with known severe hypersensitivity reactions to Bludigo® or other dyes including contrast agents.
- E04. Patients with a history of, or being evaluated or treated for, gynecologic, renal, or urogenital (ureteral or bladder) cancer.
- E05. Patients with known congenital cardiac conditions or who have a history of arrythmia, hypotension, hypertension, bradycardia or tachycardia.
Show all 12Show fewer
- E06. Patients, as assessed by the Investigator, with other conditions / concomitant diseases precluding their safe participation in this study (e.g., major systemic diseases).
- E07. Unable to meet specific protocol requirements (e.g., scheduled visits), or has a condition that could lead to non-compliance with the study procedures or patient/parent/LAR uncooperative.
- E08. Patient is the child of Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- E09. Patients with a life expectancy ≤ 6 months.
- E10. Requirement for concomitant treatment with renal tubule transport inhibitors or with any treatment that could potentially discolor urine (see section 6.6)
- E11. Patients who are pregnant or breast feeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rahul Poria, MS, RPh contact
About this study
Official title: An Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics and Conspicuity of Bludigo® When Used as an Aid in the Determination of Ureteral Patency in Pediatric Patients
This is an open-label, multicenter study to evaluate the safety, pharmacokinetics, and conspicuity of a weight-based Bludigo® dose (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL and not to exceed 2.5 mL) when used as an aid in the determination of ureteral patency in pediatric patients.
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States.
Read more
Patients scheduled for urological or gynecological surgical procedures who are < 17 years will be screened for participation.
A minimum of 6 patients will be enrolled in each of the following three age groups: birth to <6-years old, 6 to < 12 years old, 12 to < 17 years old.
Screening will occur within 30 days before study drug administration (Day of Surgery).
After signing the informed consent, review of inclusion and exclusion criteria will be performed. The collection of medical history and concomitant medications, the completion of a physical examination including vital signs measurement, ECG, and the collection of baseline laboratory testing (samples must be collected within 14 days of day 1) will be completed during the screening period.
On the Day of Surgery (Day 1) patients will be evaluated for eligibility for treatment.
To evaluate the efficacy outcomes, each patient will be injected with a weight-based dose of Bludigo® (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL) the maximum dose to be injected is not to exceed 2.5 mL. The ureteral orifices / urine jet will be observed, and a video will be recorded for 10 minutes. The time that will be captured on video is from the time of Bludigo® injection to 10 minutes post injection. If both ureters cannot be visualized simultaneously, then alternating 15-30 second images of each ureter or ureteral orifice will be obtained. The surgeon should note the time blue color is visualized in each ureter jet stream.
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo® injection.
All treated patients will have a follow-up visit 14 (± 3) days after the procedure. A final telephone call to assess adverse events (AEs) will occur at Day 30 (±2 days).
Safety assessments will include monitoring of vital signs, AEs and laboratory testing post the procedure.
Read the detailed description
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States.
Patients scheduled for urological or gynecological surgical procedures who are < 17 years will be screened for participation.
A minimum of 6 patients will be enrolled in each of the following three age groups: birth to <6-years old, 6 to < 12 years old, 12 to < 17 years old.
Screening will occur within 30 days before study drug administration (Day of Surgery).
After signing the informed consent, review of inclusion and exclusion criteria will be performed. The collection of medical history and concomitant medications, the completion of a physical examination including vital signs measurement, ECG, and the collection of baseline laboratory testing (samples must be collected within 14 days of day 1) will be completed during the screening period.
On the Day of Surgery (Day 1) patients will be evaluated for eligibility for treatment.
To evaluate the efficacy outcomes, each patient will be injected with a weight-based dose of Bludigo® (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL) the maximum dose to be injected is not to exceed 2.5 mL. The ureteral orifices / urine jet will be observed, and a video will be recorded for 10 minutes. The time that will be captured on video is from the time of Bludigo® injection to 10 minutes post injection. If both ureters cannot be visualized simultaneously, then alternating 15-30 second images of each ureter or ureteral orifice will be obtained. The surgeon should note the time blue color is visualized in each ureter jet stream.
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo® injection.
All treated patients will have a follow-up visit 14 (± 3) days after the procedure. A final telephone call to assess adverse events (AEs) will occur at Day 30 (±2 days).
Safety assessments will include monitoring of vital signs, AEs and laboratory testing post the procedure.
- Conditions
- Ureter Injury
- Being tested
- Indigotindisulfonate sodium 0.8% injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigotindisulfonate sodium 0.8% injectionDrug
Also called Bludigo®
Experimental contrast dye for diagnostic procedures, commonly used as a visualization aid in pelvic and abdominal surgeries, as well as for evaluating ureteral patency.
| Study group | Role | What they receive |
|---|---|---|
| Weight-based dose | Experimental | open label evaulation of weight based dose of Bludigo Receives: Drug: Indigotindisulfonate sodium 0.8% injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders to Bludigo®
Urine jet conspicuity scores based on the 5-point conspicuity score utilized in study PVP-19IC01 in adults. The 5-point scale is defined as:
- 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
Measured: 10 minutes post study drug administration
Secondary outcomes (5)
Time to visualization
Time to visualization of blue color at each ureteral orifice following administration of Bludigo®.
Measured: 10 minutes post drug administration
Pharmacokinetics parameters
Amount of Bludigo® excreted in urine.
Measured: 2 hours post study drug administration
Area under the curve
Area under the curve
Measured: 40 minutes post study drug administration
Maximum plasma concentration (C max)
Maximum plasma concentration (C max)
Measured: 40 minutes post study drug administration
Time to reach maximum plasma concentration (T max)
Time to reach maximum plasma concentration (T max)
Measured: 40 minutes post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prove pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Provepharm SAS
- Responsible party
- Sponsor
- Investigators
- Lisa Schwartz, Study director, Provepharm SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448143
- Sponsor's protocol ID
- PVP-21IC03
- Status last verified
- Oct 2026
- First submitted
- 20 May 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics and Conspicuity of Bludigo® When Used as an Aid in the Determination of Ureteral Patency in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06448143
- Acronym / sponsor ID
- PVP-21IC03
- Conditions
- Ureter Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Prove pharmIndustry (pharma, biotech, devices)
- Collaborators
- Provepharm SAS
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter study to evaluate the safety, pharmacokinetics, and conspicuity of a weight-based Bludigo® dose (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL and not to exceed 2.5 mL) when used as an aid in the determination of ureteral patency in pediatric patients.
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States.
Patients scheduled for urological or gynecological surgical procedures who are < 17 years will be screened for participation.
A minimum of 6 patients will be enrolled in each of the following three age groups: birth to <6-years old, 6 to < 12 years old, 12 to < 17 years old.
Screening will occur within 30 days before study drug administration (Day of Surgery).
After signing the informed consent, review of inclusion and exclusion criteria will be performed. The collection of medical history and concomitant medications, the completion of a physical examination including vital signs measurement, ECG, and the collection of baseline laboratory testing (samples must be collected within 14 days of day 1) will be completed during the screening period.
On the Day of Surgery (Day 1) patients will be evaluated for eligibility for treatment.
To evaluate the efficacy outcomes, each patient will be injected with a weight-based dose of Bludigo® (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL) the maximum dose to be injected is not to exceed 2.5 mL. The ureteral orifices / urine jet will be observed, and a video will be recorded for 10 minutes. The time that will be captured on video is from the time of Bludigo® injection to 10 minutes post injection. If both ureters cannot be visualized simultaneously, then alternating 15-30 second images of each ureter or ureteral orifice will be obtained. The surgeon should note the time blue color is visualized in each ureter jet stream.
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo® injection.
All treated patients will have a follow-up visit 14 (± 3) days after the procedure. A final telephone call to assess adverse events (AEs) will occur at Day 30 (±2 days).
Safety assessments will include monitoring of vital signs, AEs and laboratory testing post the procedure.
Detailed description
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States.
Patients scheduled for urological or gynecological surgical procedures who are < 17 years will be screened for participation.
A minimum of 6 patients will be enrolled in each of the following three age groups: birth to <6-years old, 6 to < 12 years old, 12 to < 17 years old.
Screening will occur within 30 days before study drug administration (Day of Surgery).
After signing the informed consent, review of inclusion and exclusion criteria will be performed. The collection of medical history and concomitant medications, the completion of a physical examination including vital signs measurement, ECG, and the collection of baseline laboratory testing (samples must be collected within 14 days of day 1) will be completed during the screening period.
On the Day of Surgery (Day 1) patients will be evaluated for eligibility for treatment.
To evaluate the efficacy outcomes, each patient will be injected with a weight-based dose of Bludigo® (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL) the maximum dose to be injected is not to exceed 2.5 mL. The ureteral orifices / urine jet will be observed, and a video will be recorded for 10 minutes. The time that will be captured on video is from the time of Bludigo® injection to 10 minutes post injection. If both ureters cannot be visualized simultaneously, then alternating 15-30 second images of each ureter or ureteral orifice will be obtained. The surgeon should note the time blue color is visualized in each ureter jet stream.
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo® injection.
All treated patients will have a follow-up visit 14 (± 3) days after the procedure. A final telephone call to assess adverse events (AEs) will occur at Day 30 (±2 days).
Safety assessments will include monitoring of vital signs, AEs and laboratory testing post the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight-based dose | Experimental | Drug: Indigotindisulfonate sodium 0.8% injectionopen label evaulation of weight based dose of Bludigo |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- I01. Patients from birth to < 17 years
- I02. Patients whose Parents or Legal Authorized Representative (LAR) have signed a written, IRB approved, informed consent form (ICF) and applicable assent obtained.
- I03. Patients scheduled for urological or gynecological surgical procedures in which the patency of the ureters must be assessed by the surgeon during the surgery.
Key exclusion criteria (12 listed)
- E01. For patients ≥ 1 year of age, Stage 5 Chronic Kidney Failure (defined as an eGFR (estimated glomerular filtration rate) ≤ 15mL/min/1.73 m2). (Calculated using the revised "Bedside Schwartz" equation (Schwartz et al. 2009) ). The revised "Bedside Schwartz" for eGFR is calculated as follows. eGFR (mL/min/1.73m2) = 0.413 height/Scr, where height is baseline height measured in cm and Scr is baseline serum creatine measured in mg/dL;
- For patients less than 1 year of age, measured serum creatinine greater than 1.5-times the upper limit of normal (>97.5 percentile) based on the reference table in Boer et al., 2010.
- E02. Patients weighing less than 5 kgs.
- E03. Patients with known severe hypersensitivity reactions to Bludigo® or other dyes including contrast agents.
- E04. Patients with a history of, or being evaluated or treated for, gynecologic, renal, or urogenital (ureteral or bladder) cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigotindisulfonate sodium 0.8% injectionAlso: Bludigo®Experimental contrast dye for diagnostic procedures, commonly used as a visualization aid in pelvic and abdominal surgeries, as well as for evaluating ureteral patency. | Drug | Weight-based dose |
Primary outcome
Responders to Bludigo®
Time frame: 10 minutes post study drug administration
Urine jet conspicuity scores based on the 5-point conspicuity score utilized in study PVP-19IC01 in adults. The 5-point scale is defined as: 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
5 secondary outcomes
Time to visualization
Time frame: 10 minutes post drug administration
Pharmacokinetics parameters
Time frame: 2 hours post study drug administration
Area under the curve
Time frame: 40 minutes post study drug administration
Maximum plasma concentration (C max)
Time frame: 40 minutes post study drug administration
Time to reach maximum plasma concentration (T max)
Time frame: 40 minutes post study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Poria, MS, RPh contact
Lisa Schwartz study director
Provepharm SAS
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indigotindisulfonate sodium 0.8% injection in people with Ureter Injury, run by Prove pharm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Schwartz (773-209-4076, lisa.schwartz.contract@provepharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders to Bludigo® (time frame: 10 minutes post study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.