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

Recruiting Phase 4 Interventional Study
Ureter Injury
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Diagnostic
Participants needed
116 (estimated)
Sponsor
Prove pharm · Industry
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About This Trial

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.

Trial Locations
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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…
Contacts

Michelle Boytim, Ph.D.

610-850-7115

michelle.boytim@provepharm.com

CONTACT