Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
ConditionUreter Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorProve pharm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Indigotindisulfonate sodium 0.8%
DrugExperimental 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 interventionPlacebo
Treatment groups
116 Participants
are divided into 3 treatment groupsGroup A: SalinePlacebo comparator 1 intervention
Group B: High DoseExperimental treatment 2 interventions
Group C: Low DoseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
10 minutes post study drug administration2
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.
Time frame
10 Minutes post study drug administrationSecondary outcomes
1
Incidence of adverse events and serious adverse events.
Percentage of patients in each treatment group who experience an adverse event post treatment
Time frame
30 days post study drug administration2
Changes in clinical safety laboratory values
Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment
Time frame
30 days post study drug administration3
Changes in vital signs post treatment
Proportion of subjects with clinically important changes in vital signs after treatment
Time frame
30 days post study drug administration4
Changes in ECG post treatment
Proportion of subjects with clinically important changes in ECGs after treatment
Time frame
30 days post study drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov