Kidney Stones Clinical Trials

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Access Sheath and stENT Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
MUSIC Coordinating Center
esekulos@med.umich.edu
734-232-4906
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2026-10
Participants
Target number of participants: 184
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov