Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02677623 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
A Phase 4 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
NCT02677623 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 140 participants.
The verdict
NCT02677623, a Phase 4 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
Study Summary
Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to identify the opening of the ureters to ensure that they are working correctly. Historically, indigo carmine, an intravenous medication that dyes the urine blue, has been used to help visualize the opening of the ureters with cystoscopy which is a camera placed inside the bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus, investigators need to evaluate other methods for assessing ureteral patency. Ideal alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are readily available and are easy to use. Examples of such agents currently being used to evaluate the ureters, include oral pyridium, IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by either dyeing the urine a different color such as pyridium and sodium fluorescein, or by having a different viscosity to urine such as mannitol. This study will compare three methods of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium fluorescein, and pyridium.
Interventions
- OTHER Normal Saline
- DRUG Mannitol
- DRUG Sodium Fluorescein
- DRUG Pyridium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02677623
The ClinicalTrials.gov registry entry for NCT02677623 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Normal Saline is the first listed.
NCT02677623 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02677623 about?
NCT02677623 is a clinical study titled "Evaluation of Ureteral Patency in the Post-indigo Carmine Era". Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to identify the opening of the ureters to ensure that they are working correctly. Historically, indigo carmine, an intravenous medication that dyes the urine blue, has been used to help visualize the opening of the ...
What is the current status of trial NCT02677623?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2015-03. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02677623?
The interventions under investigation include: Normal Saline (OTHER), Mannitol (DRUG), Sodium Fluorescein (DRUG), Pyridium (DRUG).
Who is sponsoring clinical trial NCT02677623?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.