Indigotindisulfonate sodium 0.8%: 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%: Placebo
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score . — 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 — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.