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Clinical Trial Summary

To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution for injection provides a visualization advantage compared to saline when used as an aid in the determination of ureteral patency


Clinical Trial Description

This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of two doses (2.5 mL and 5.0 mL) of 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from approximately 10 study centers in the United States. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04228445
Study type Interventional
Source Prove pharm
Contact
Status Completed
Phase Phase 3
Start date February 13, 2020
Completion date June 3, 2021

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