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NCT06576661NARecruitingAccepts Healthy Volunteers

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

University of Kansas Medical Center

Start Date

1/28/2025

Completion Date

11/1/2026

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.

Detailed Description

Despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. Therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. The new LithoVue Elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

INTRARENAL PRESSURE MONITORING VISIBLE

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Conditions

Kidney StoneNephrolithiasis

Locations

University of Kansas Medical Center

Kansas City, Kansas 66160

United States