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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 is a Early Phase 1 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 120 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03432572
The ClinicalTrials.gov registry entry for NCT03432572 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Tech University Health Sciences Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Thiamine is the first listed.
NCT03432572 reports 0 study locations.
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.
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