Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) (NCT05026710) | Clinical Trial Compass
CompletedNot Applicable
Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
United States224 participantsStarted 2021-12-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days
Timeframe: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
2
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days
Timeframe: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.