CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 224 enrolled
Drug / intervention
Silicone (Coloplast Imajin Hydro) ureteral stent +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05026710
NCT05026710N/ACompleted
CompareCT.gov

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study

University of Michigan·interventional·Posted Aug 30, 2021·Updated Oct 28, 2025

In Brief

A clinical study evaluating Silicone (Coloplast Imajin Hydro) ureteral stent and Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer) for Renal Stone and Ureteral Stone. Completed, enrolled 224 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Stone, Ureteral Stone
CountriesUnited States
CollaboratorsColoplast A/S

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 30, 2021
Enrollment StartDec 2, 2021
Primary CompletionJul 1, 2024
Study CompletionAug 21, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.8 years ago

Interventions

Silicone (Coloplast Imajin Hydro) ureteral stentdevice

During the end of the standard of care ureteroscopy the silicone stent will be placed.

Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)device

During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.