NCT05026710

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Stone
• Ureteral Stone

Interventions

Type	Name	Description
DEVICE	Silicone (Coloplast Imajin Hydro) ureteral stent	During the end of the standard of care ureteroscopy the silicone stent will be placed.
DEVICE	Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)	During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.

Timeline

• Start date: 2021-12-02
• Primary completion: 2024-07-01
• Completion: 2024-08-21
• First posted: 2021-08-30
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study