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Completed
NCT06054880
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
Conditions: Ureter Injury
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 117
Sponsor: Prove pharm
Location: Albany Medical Center Albany New York
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 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 \
Source: ClinicalTrials.gov (NCT06054880). StuddyBuddy aggregates publicly available trial information.
