💬In plain words
What the trial is, and whether it could suit you
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.
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📋 Eligibility rules (as published)
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
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