Silicone vs Non-Silicone Stents for Kidney Stones
(BLUES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if a silicone stent works better for patients who have had surgery on their ureter. The silicone stent helps keep the ureter open so urine can flow easily. Silicone stents are generally better tolerated compared to other materials.
Who Is on the Research Team?
Khurshid Ghani, MD, MS, FRCS
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
The BLUES trial is for individuals with kidney or ureter stones who can take oral medication and are willing to follow the study's procedures. They must have stones no larger than 2cm, need a stent without a string after surgery, and be able to complete surveys. Pregnant women, those allergic to polyurethane or silicone, with certain anatomical anomalies or prior urinary diversions cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to receive either the Imajin silicone stent or a non-silicone stent after ureteroscopy
Follow-up
Participants complete questionnaires and have follow-up information collected to assess outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
- Silicone (Coloplast Imajin Hydro) ureteral stent
- Ureteroscopy
Ureteroscopy is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Coloplast A/S
Industry Sponsor
Kristian Villumsen
Coloplast A/S
Chief Executive Officer since 2018
Master's degree in Political Science from Aarhus University
Preeti Jain
Coloplast A/S
Chief Medical Officer since 2023
MD from University of Copenhagen