Ureter InjuryPhase 4NCT06054880
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
A Phase 4 study testing Indigotindisulfonate sodium 0.8% and Saline injection 0.9% in people with Ureter Injury, run by Prove pharm at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ureter Injury
- What is being tested?
- Indigotindisulfonate sodium 0.8% and Saline injection 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Subjects with life expectancy < 6 months
- Requirement for concomitant treatment that could bias primary evaluation.
- Subjects who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency
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.
Read the detailed description
Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. 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 concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.
- Conditions
- Ureter Injury
- Being tested
- Indigotindisulfonate sodium 0.8%, Saline injection 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigotindisulfonate sodium 0.8%Drug
Also called Bludigo
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 injection 0.9%Other
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | 116 subjects treated with 5 ml of saline then crossover to treatment arm Receives: Other: Saline injection 0.9% |
| High Dose | Experimental | 58 subjects randomly treated with 5 mL of drug Receives: Drug: Indigotindisulfonate sodium 0.8%; Other: Saline injection 0.9% |
| Low Dose | Experimental | 58 subjects randomly treated with 2.5 mL of drug Receives: Drug: Indigotindisulfonate sodium 0.8%; Other: Saline injection 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = 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
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.
Measured: 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:
- = 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
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.
Measured: 10 Minutes post study drug administration
Secondary outcomes (9)
Incidence of adverse events and serious adverse events.
Percentage of patients in each treatment group who experience an adverse event post treatment
Measured: 30 days post study drug administration
Changes in clinical safety laboratory values
Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment
Measured: 30 days post study drug administration
Changes in vital signs post treatment
Proportion of subjects with clinically important changes in vital signs after treatment
Measured: 30 days post study drug administration
Changes in ECG post treatment
Proportion of subjects with clinically important changes in ECGs after treatment
Measured: 30 days post study drug administration
Changes in blood pressure by dose group and BMI (kg/m^2)
Comparison of post treatment changes in blood pressure by dose group and BMI (kg/m^2)
Measured: 30 days post study drug administration
Changes in heart rate by dose group and BMI (kg/m^2)
Comparison of post treatment changes in heart rate by dose group and BMI (kg/m^2)
Measured: 30 days post study drug administration
Changes in pulse oximetry by dose group and BMI (kg/m^2)
Comparison of post treatment changes in pulse oximetry by dose group and BMI (kg/m^2)
Measured: 30 days post study drug administration
Physician Satisfaction
To determine physicians' overall satisfaction with the Bludigo™ treatment by assessing the proportion of surgeons who agree using the 5-point Physician Satisfaction Agreement Scale (PSAS) with the statement:
"Compared to the saline treatment, my ability to assess ureter patency was improved after the addition of Bludigo™."
- = Strongly Agree
- = Agree
- = Neither Agree nor Disagree
- = Disagree
- = Strongly Disagree A surgeon's evaluation is considered satisfactory if the rating is either a 1 (strongly agree) or 2 (agree).
Measured: 10 Minutes post study drug administration
Time to visualization
To describe the time to visualization (TTV) of blue color in the ureteral jets flow following Bludigo™ treatment
Measured: 10 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 posted26 Sep 2023
- Study start12 Oct 2023
- Primary completion30 Mar 2026
- Study completion31 Mar 2026
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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prove pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Boytim, Ph.D., Study director, Provepharm SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054880
- Sponsor's protocol ID
- PVP-22IC04
- Status last verified
- Nov 2026
- First submitted
- 30 Aug 2023
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency
- ClinicalTrials.gov ID
- NCT06054880
- Acronym / sponsor ID
- PVP-22IC04
- Conditions
- Ureter Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Prove pharmIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 26 Sep 2023 (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 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.
Detailed description
Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. 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 concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: Saline injection 0.9%116 subjects treated with 5 ml of saline then crossover to treatment arm |
| High Dose | Experimental | Drug: Indigotindisulfonate sodium 0.8%, Other: Saline injection 0.9%58 subjects randomly treated with 5 mL of drug |
| Low Dose | Experimental | Drug: Indigotindisulfonate sodium 0.8%, Other: Saline injection 0.9%58 subjects randomly treated with 2.5 mL of drug |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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%Also: BludigoExperimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. | Drug | High Dose, Low Dose |
| Saline injection 0.9%Placebo | Other | High Dose, Low Dose, Saline |
Primary outcome
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .
Time frame: 10 minutes post study drug administration
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.
Responders to Bludigo
Time frame: 10 Minutes post study drug administration
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.
9 secondary outcomes
Incidence of adverse events and serious adverse events.
Time frame: 30 days post study drug administration
Changes in clinical safety laboratory values
Time frame: 30 days post study drug administration
Changes in vital signs post treatment
Time frame: 30 days post study drug administration
Changes in ECG post treatment
Time frame: 30 days post study drug administration
Changes in blood pressure by dose group and BMI (kg/m^2)
Time frame: 30 days post study drug administration
Changes in heart rate by dose group and BMI (kg/m^2)
Time frame: 30 days post study drug administration
Changes in pulse oximetry by dose group and BMI (kg/m^2)
Time frame: 30 days post study drug administration
Physician Satisfaction
Time frame: 10 Minutes post study drug administration
Time to visualization
Time frame: 10 minutes post study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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. This study is not recruiting at the moment.
Michelle Boytim, Ph.D. study director
Provepharm SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indigotindisulfonate sodium 0.8% and Saline injection 0.9% in people with Ureter Injury, run by Prove pharm at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score . (time frame: 10 minutes post study drug administration). The study lists 2 primary outcomes in all. 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 5 Nov 2026.