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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: Completed Phase 4 study, sponsored by Columbia University.
NCT02677623 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is a 10-cm visual analog scale to determine which method of evaluating ureteral patency is most satisfactory to physicians. The smiley face is at one end and the frowning face is at the other end. Smiling is 1 and frowning is 10. The scale is completed by surgeon, anesthesiologist and the circulator by placing an "x" or a "mark" anywhere on the 10 cm line towards how good and or bad each person felt about the of process of patency assessment that was used. Using a ruler, the score is determ
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 |
What the finished NCT02677623 record still lists
NCT02677623 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Normal Saline is the first listed.
NCT02677623 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02677623's enrollment target sits among peer trials
140 581st of 2000 higher than 1,408 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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