Status:
RECRUITING
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
Lead Sponsor:
Prove pharm
Conditions:
Ureter Injury
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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™ (indigotindisulfonate Sodium Injection, USP) 0.8% when used as an aid in ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06054880
Start Date
October 12 2023
End Date
January 31 2026
Last Update
November 3 2025
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12008