At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 121 enrolled
Drug / intervention
3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study of Two Different Doses of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution When Used as an Aid for Ureteral Patency
In Brief
A Phase 3 clinical trial evaluating 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% and Saline spray for Ureter Injury. Completed, enrolled 121 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUreter Injury
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartFeb 2020
Primary CompletionJun 2021
TodayJul 2026
First PostedJan 14, 2020
Enrollment StartFeb 13, 2020
Primary CompletionJun 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.5 years ago
Interventions
3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%drug
Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
Saline spraydrug
Placebo