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NCT05026710 · ClinicalTrials.gov registry record · NA
Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 224
- Enrollment target
NCT05026710: Completed NA study, sponsored by University of Michigan.
NCT05026710 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 224 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05026710, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 224 participants
- Enrollment target
Study Summary
This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy. Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent. In addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery). The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.
Primary Outcome
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Interventions
- DEVICE Silicone (Coloplast Imajin Hydro) ureteral stent
- DEVICE Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2021-12-02 |
| Est. Completion | 2024-08-21 |
| Phase | NA |
What the finished NCT05026710 record still lists
NCT05026710 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Silicone (Coloplast Imajin Hydro) ureteral stent is the first listed.
NCT05026710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05026710 about?
NCT05026710 is a clinical study titled "Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)". This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy. Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent...
What is the current status of trial NCT05026710?
This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2021-12-02. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT05026710?
The interventions under investigation include: Silicone (Coloplast Imajin Hydro) ureteral stent (DEVICE), Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer) (DEVICE).
Who is sponsoring clinical trial NCT05026710?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05026710's enrollment target sits among peer trials
224 478th of 2000 higher than 1,520 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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