Access Sheath and Stent Trial
Recruiting now · Not applicable
Conditions studied: Kidney Stone, Ureteral Stone
In brief
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy. 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.
Key facts
- Study ID
- NCT07297953
- Run by
- University of Michigan
- People needed
- 184
- Starts
- 2025-09-24
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of signed and dated informed consent form
- 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.
You may not qualify if…
- Pregnancy
- 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
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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