| NCT ID | NCT07297953 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2025-09-24 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Khurshid Ghani, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07297953 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07297953 currently recruiting?
Yes, NCT07297953 is actively recruiting participants. Contact the research team at esekulos@med.umich.edu for enrollment information.
Where is the NCT07297953 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07297953 clinical trial?
NCT07297953 is sponsored by University of Michigan. The principal investigator is Khurshid Ghani, MD at University of Michigan. The trial plans to enroll 184 participants.
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