Clinical trial Recruiting at 1 site Interventional Ages 18 and up

LithoVue Elite ureteroscope with real‑time kidney pressure monitoring during flexible ureteroscopy.

Official title: Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes

Run by University of Kansas Medical Center · NCT06576661 · Data updated 2026-11-12

This test will see if showing surgeons real‑time kidney pressure readings during flexible ureteroscopy changes how they operate and affects outcomes for adults having ureteroscopy for kidney or proximal ureter stones larger than 2 cm.

More Kidney Stone trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorUniversity of Kansas Medical Center
Academic / other
Locations1 site (Kansas City, Kansas)
StatusRecruiting
StartedJanuary 28, 2025
Main results expectedNovember 1, 2026
Study endsNovember 1, 2026
Registry record updatedMay 4, 2026
Trial IDNCT06576661 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older undergoing flexible ureteroscopy for kidney or proximal ureter stones with a total stone burden over 2 cm who do not have major anatomic abnormalities, urinary diversions, chronic external catheters, uncorrected coagulopathy, pregnancy, or immunosuppression are the ideal candidates.

Probably not a fit

Patients undergoing bilateral stone treatment in the same procedure, those with known genitourinary anatomical abnormalities, urinary diversions, chronic external catheters, uncorrected coagulopathy, pregnancy, or immunosuppression are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study compares surgeon behavior and post‑operative outcomes during flexible ureteroscopy using the LithoVue Elite disposable ureteroscope with intrarenal pressure monitoring visible versus not visible. Surgeons are observed for intraoperative non‑technical skills and procedural decisions while real‑time pressure data are recorded. Postoperative outcomes and complications are tracked to see whether access to pressure data correlates with safer technique or different clinical results. The focus is on adults undergoing ureteroscopy for proximal ureter or kidney stones with total stone burden over 2 cm.

Why it matters

Potential benefit: If successful, this approach could help surgeons avoid high intrarenal pressures during ureteroscopy and reduce pressure‑related complications, improving patient safety.

How similar studies have gone: Previous research has linked high intrarenal pressures to complications and measured pressures during ureteroscopy, but using a disposable ureteroscope with integrated, visible real‑time pressure monitoring to change surgeon behavior is relatively novel and not yet widely validated.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Males or females over 18 years of age
* Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney
* Total stone burden over 2 cm

Exclusion Criteria:

1. Undergoing bilateral stone treatment during the same procedure
2. Patients with known genitourinary anatomical abnormalities
3. Uncorrected coagulopathy
4. Patients with urinary diversions
5. Chronic external urinary catheters
6. Women who are pregnant
7. Immunosuppressed patients

Where it's running

  • University of Kansas Medical Center
    Kansas City, Kansas, United States
    Recruiting

Study contacts

  • Principal investigator: Bristol B Whiles, MD — University of Kansas Medical Center
  • Study coordinator: Jane Ledesma
  • Email: jledesma2@kumc.edu
  • Phone: 19135888721

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.