drugset / Trial / NCT04228445
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
RandomizedSequentialQuadruple-blindDiagnostic
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
Timeline
- Start
- 2020-02-13
- Primary completion
- 2021-06-03
- Completion
- 2021-06-03
Outcome
Met primary endpoint
registry analysis (superiority test); HIGH DOSE vs Saline; p <0.0001; Odds Ratio (OR) 14.041 (95% CI 7.394 to 26.662); Score statistics for Type 3 GEE analysis NCT04228445 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium | Diagnostic / imaging agent | 2.5 ml | — |
| Subject | 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium | Diagnostic / imaging agent | 5 ml | — |