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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Status | Recruiting |
| Started | January 28, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06576661 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Observation vs Upfront Surgery for Asymptomatic Kidney Stones in Children and Adults
This trial tests whether watching asymptomatic kidney stones or performing upfront surgery is better for reducing life disruption in patients aged 6 and older.
-
Ho:YAG versus thulium fiber laser for mini-PCNL with the ClearPetra suction sheath
This trial will see if the Ho:YAG or thulium fiber laser clears kidney stones better during mini-PCNL with the ClearPetra suction sheath in adults with stones larger than 15 mm.
-
Empagliflozin and personalized diet for preventing calcium kidney stones
This study tests whether the diabetes drug empagliflozin plus tailored dietary counseling can reduce recurrent calcium kidney stones in adults.
-
Investigating how the gut absorbs oxalate in kidney stone patients
This study is trying to see if people with kidney stones absorb more oxalate from their diet than healthy individuals, which might lead to more oxalate in their urine.
-
Using gut bacteria to reduce urinary oxalate in kidney stone patients
This study is testing if introducing a specific gut bacteria can help adults with calcium oxalate kidney stones lower the amount of oxalate in their urine.
-
Predicting kidney stone recurrence and complications using precision medicine
This study is trying to find out what causes kidney stones to come back so that we can help people avoid getting them again.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.