Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
184 participants
INTERVENTIONAL
2025-09-24
2026-10-31
Brief Summary
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Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion.
Hypothesis:
\- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Stent omission arm
Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.
Surveys
Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.
Stent placement arm
Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.
Surveys
Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.
Interventions
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Surveys
Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.
Eligibility Criteria
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Inclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
* Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
* Renal stone defined as only renal location of stone(s)
* Ureteral stone defined as ureteral only location of stone(s)
* Ureteral and renal stone(s)
* No evidence of significant ureteral injury on intra-operative assessment (Post-Ureteroscopy Lesion Scale (PULS) Grade 0 or 1)
* Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
Exclusion Criteria
* Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
* Evidence of ureteral stricture
* Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
* Known planned secondary or staged procedure
* Indwelling nephrostomy tube
* Bilateral ureteroscopy
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Khurshid Ghani
Clinical Professor of Urology
Principal Investigators
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Khurshid Ghani, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Elaina Shoemaker
Role: primary
Other Identifiers
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HUM00264257
Identifier Type: -
Identifier Source: org_study_id