Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
NCT ID: NCT05026710
Last Updated: 2025-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
224 participants
INTERVENTIONAL
2021-12-02
2024-08-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Silicone (Coloplast Imajin Hydro) ureteral stent
Silicone (Coloplast Imajin Hydro) ureteral stent
During the end of the standard of care ureteroscopy the silicone stent will be placed.
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
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.
Interventions
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Silicone (Coloplast Imajin Hydro) ureteral stent
During the end of the standard of care ureteroscopy the silicone stent will be placed.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
University of Michigan
OTHER
Responsible Party
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Khurshid Ghani
Associate Professor of Urology
Principal Investigators
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Khurshid Ghani, MD, MS, FRCS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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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
Countries
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References
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Becker REN, DiBianco JM, Higgins AM, Konheim J, Kleer E, Leavitt D, King A, Kachroo N, Majdalany SE, Gandham D, Fernandez Moncaleano G, Conrado B, Shoemaker E, Daignault-Newton S, Dauw CA, Ghani KR. Daily Ecological Momentary Assessments of Pain and Ability to Work After Ureteroscopy and Stenting. J Endourol. 2024 Jun;38(6):545-551. doi: 10.1089/end.2023.0625.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUM00199486
Identifier Type: -
Identifier Source: org_study_id
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