Recruiting

LithoVue Elite

Sponsor:

University of Kansas Medical Center

Code:

NCT06576661

Conditions

Kidney Stone

Nephrolithiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

INTRARENAL PRESSURE MONITORING VISIBLE

Study Details

Brief summary:

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

Conditions

Kidney Stone

Nephrolithiasis

Study ID

NCT06576661

Start date

Jan 28, 2025

Status verified date

May, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: URS WITH INTRARENAL PRESSURE MONITORING VISIBLE

In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.

no intervention: URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLE

In Arm 2, participants will undergo URS LithoVue Elite™ without the real-time IRP monitoring information visible to the surgeon. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.

Interventions

INTRARENAL PRESSURE MONITORING VISIBLE

In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.

Primary outcome measure

  • Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score. [ Time Frame: Procedure ]

Central Contacts and Locations

Central contacts

Jane Ledesma

19135888721jledesma2@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jane Ledesma, BS

913-588-8721jledesma2@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 4, 2026

Last verified

May, 2026

Keywords

  • Intrarenal Pressure
  • LithoVue Elite

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-04.