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NCT04228445 · ClinicalTrials.gov registry record · Phase 3
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
A Phase 3 study of Ureter Injury, sponsored by Prove pharm.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
- 1
- Study location
NCT04228445: Completed Phase 3 study of Ureter Injury, sponsored by Prove pharm.
NCT04228445 is a Phase 3 study of Ureter Injury that has completed, run by Prove pharm. The registered enrollment target is 121 participants, above the 91-participant average among 5 other Ureter Injury trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228445, a Phase 3 study of Ureter Injury, has completed, sponsored by Prove pharm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color
Conditions Studied
Interventions
- DRUG Saline spray
- DRUG 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%
Study Locations (1)
Nebraska
- Adult and Pediatric Urology - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2020-02-13 |
| Est. Completion | 2021-06-03 |
| Phase | Phase 3 |
What the finished NCT04228445 record still lists
NCT04228445 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 91-participant average among 5 other Ureter Injury trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 2 interventions - of which Saline spray is the first listed.
NCT04228445 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT04228445 about?
NCT04228445 is a clinical study titled "3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency". 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
What is the current status of trial NCT04228445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2020-02-13. Estimated completion is 2021-06-03.
What conditions does trial NCT04228445 study?
This clinical trial studies the following conditions: Ureter Injury.
What interventions are being tested in trial NCT04228445?
The interventions under investigation include: Saline spray (DRUG), 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% (DRUG).
Who is sponsoring clinical trial NCT04228445?
This trial is sponsored by Prove pharm, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04228445 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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