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

Launched by PROVE PHARM · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Bludigo™ (indigotindisulfonate Sodium Injection, USP) to help doctors determine if the ureters—tubes that carry urine from the kidneys to the bladder—are open and functioning properly after surgery. The trial involves people aged 18 to 85 years who are scheduled for a procedure where this check needs to be done. Participants will be randomly assigned to receive either a higher or lower dose of Bludigo™, along with a dose of normal saline for comparison.

To be eligible for this study, participants should be in good overall health and not have severe kidney problems or certain other medical conditions. During the trial, participants will have their health monitored closely before, during, and after the procedure, with follow-up visits to ensure their safety. This study is important because it aims to improve the way doctors assess ureteral function, which can lead to better patient outcomes.

Gender

ALL

Eligibility criteria

• 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