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Silicone vs Non-Silicone Stents for Kidney Stones (BLUES Trial)
BLUES Trial Summary
This trial is comparing patient outcomes related to the Imajin silicone stent to non-silicone polyurethane stents after ureteroscopy.
BLUES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBLUES Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BLUES Trial Design
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Who is running the clinical trial?
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- I need a follow-up procedure to remove leftover kidney stone pieces after surgery.I am willing and able to follow all study rules and attend all appointments.I have had surgery to redirect urine flow.I am scheduled for a procedure to examine my ureter with stent placement without a stent string.You have a tube in your ureter before the procedure.My kidney stones are located only in my kidneys or ureters.I have a tube inserted into my kidney.I have kidney or ureter stones smaller than 2.0 cm.I have a stone in my ureter, with or without kidney stones.I can take pills by mouth.I have kidney stones located only in my kidneys.I have a bladder stone.I have a kidney stone in a specific part of my kidney.You are allergic to polyurethane or silicone.I can take pills by mouth.I am willing and able to answer survey questions for the study.I don't need a stent for my condition.I have a scheduled follow-up surgery.I have a unique kidney shape or position.
- Group 1: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
- Group 2: Silicone (Coloplast Imajin Hydro) ureteral stent
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the participant total for this medical trial?
"Affirmative. Currently, this clinical trial is in the process of recruitment and data hosted on clinicaltrials.gov proves it. This medical study was initially posted on December 2nd 2021 and its latest update occurred on March 8th 2022; 224 participants are needed from 13 separate sites."
How many health centers are conducting this examination?
"The current clinical trial is running across 13 different medical sites, including those in Ann Arbor, Brighton and Royal Oak. To reduce the need to travel extensively should you decide to participate, it is advised that you pick a location closest to your home residence."
Is this research project currently open to enrollment?
"Affirmative. Clinicaltrials.gov records show that as of March 8th 2022, this clinical trial is still looking for volunteers to participate in the study, which was first posted on December 2nd 2021. A total of 224 participants are needed and 13 sites have been identified for recruitment purposes."
With what end goal are the researchers striving for in this investigation?
"The primary measure of effectiveness for this trial will be the alteration in PROMIS® scores depicting pain-interference within a 7 to 10 day timeframe. Additionally, secondary outcomes include any changes in LURN SI-10 scores concerning urinary frequency and post-micturition symptoms over the same duration as well as shifts in Patient Reported Outcomes Measurement Information System (PROMIS) results relating to pain interference 4 to 6 weeks post treatment and stone-free rates established within 60 days from initial administration."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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