Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment

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
48 (estimated)
Sponsor
Prove pharm · Industry
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About This Trial

This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.

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. * An estimated glomerular filtr…
Contacts

Michelle Boytim, P.hD.

610-850-7115

michelle.boytim@provepharm.com

CONTACT