LithoVue Elite ureteroscope with real‑time kidney pressure monitoring during flexible ureteroscopy.
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
NA · University of Kansas Medical Center · NCT06576661
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center (other) |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06576661 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kansas City, Kansas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Stone, Nephrolithiasis, Intrarenal Pressure, LithoVue Elite