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NCT03432572 · ClinicalTrials.gov registry record · Early Phase 1
Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
A Early Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 120
- Enrollment target
NCT03432572: Completed Early Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
NCT03432572 is a Early Phase 1 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 120 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03432572, a Early Phase 1 study, has completed, sponsored by Texas Tech University Health Sciences Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
Recently, Indigo Carmine and Methylene Blue have been the standard agents to visualize ureteral jets during intraoperative cystoscopy. However, due to a national shortage of Indigo Carmine and Methylene Blue, there is a need to discover alternative IV and oral agents that are readily available and well tolerated when used for visualizing ureteral jets at the time of intraoperative cystoscopy. The aim of this study is to look at oral agents that have been studied such as pyridium (Phenazopyridine Hydrochloride) and riboflavin and compare them in a three-arm double-blinded randomized controlled pilot study using riboflavin, pyridium, and a placebo. The aim of the study is to provide evidence that both pyridium and riboflavin are effective and safe for staining urine to facilitate visualization of jets in evaluating ureteral patency at the time of intraoperative cystoscopy.
Primary Outcome
To determine if oral pyridium and vitamin B riboflavin administration prior to gynecologic procedures are effective and safe alternatives for evaluating ureteral patency at the time of cystoscopy.
Interventions
- DRUG Thiamine
- DRUG Riboflavin
- DRUG Pyridium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2020-06-30 |
| Phase | Early Phase 1 |
What the finished NCT03432572 record still lists
NCT03432572 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 3 interventions - of which Thiamine is the first listed.
NCT03432572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03432572 about?
NCT03432572 is a clinical study titled "Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets". Recently, Indigo Carmine and Methylene Blue have been the standard agents to visualize ureteral jets during intraoperative cystoscopy. However, due to a national shortage of Indigo Carmine and Methylene Blue, there is a need to discover alternative IV and oral agents that are readily available and w...
What is the current status of trial NCT03432572?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 120 participants. The study started on 2018-06-27. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03432572?
The interventions under investigation include: Thiamine (DRUG), Riboflavin (DRUG), Pyridium (DRUG).
Who is sponsoring clinical trial NCT03432572?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03432572's enrollment target sits among peer trials
120 149th of 2000 higher than 1,844 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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