Access Sheath and Stent Trial

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07297953
Status
Recruiting
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Conditions

  • Kidney Stone
  • Ureteral Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surveys — OTHER
    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.

Study Details

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 Dates

Start date
Sep 24, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Other: Stent omission arm
    Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.
  • Other: Stent placement arm
    Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.

Primary Outcome Measure

Differences in PROMIS Pain Interference [ Time Frame: Baseline (before procedure), 7-10 days after procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Elaina Shoemaker
[email protected]
734-232-4906
Kurshid Ghani, MS, FRCS (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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