Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Completed · Not applicable

Conditions studied: Renal Stone, Ureteral Stone

In brief

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.

Key facts

Study ID

NCT05026710

Run by

University of Michigan

People needed

224

Starts

2021-12-02

Expected to finish

2024-08-21

Last updated by the study team

2025-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, Ultrasound or computerized tomography (CT) scan
• Renal stone defined as only renal location of stone(s).
• Ureteral stone defined as ureteral only or ureteral and renal stone(s).
• Planned unilateral ureteroscopy with stent placement without stent string.
• Ability to take oral medication.
• Ability and willingness to complete and adhere to survey questions and responses throughout study duration.

You may not qualify if…

• Known planned secondary or staged procedure
• Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney)
• Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder)
• Presence of any indwelling ureteral stent prior to ureteroscopy
• Presence of any indwelling nephrostomy tube prior to ureteroscopy
• Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery
• Renal stone located in calyceal diverticulum
• No indication for stent placement (e.g. spontaneous passage)
• Bladder stone location.
• Pregnancy or lactation
• Known allergic reactions to polyurethane or silicone

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States
• Michigan Medicine — Brighton, Michigan, United States
• Chelsea Hospital (Saint Joseph Mercy) — Chelsea, Michigan, United States
• Henry Ford Macomb Hospital — Clinton Township, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Ascension Hospital (Comprehensive Urology) — Novi, Michigan, United States
• William Beaumont Hospital (Michigan Institute of Urology) — Royal Oak, Michigan, United States
• William Beaumont Hospital (Michigan Institute of Urology) — Troy, Michigan, United States
• Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States
• Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital) — Ypsilanti, Michigan, United States

Full record on ClinicalTrials.gov

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