About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Undergoing bilateral stone treatment during the same procedure
Patients with known genitourinary anatomical abnormalities
Uncorrected coagulopathy
Patients with urinary diversions
Trial design
Parallel
Treatments tested in this trial
INTRARENAL PRESSURE MONITORING VISIBLE
DeviceIn Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.
Treatment groups
Trial outcomes
Primary outcomes
Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.
Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \& teamwork, and leadership.
Secondary outcomes
Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores
Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \& teamwork, and leadership.
Post-operative infection
Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture
Perioperative patient outcomes as measured by Clavien-Dindo classification system
Intraoperative complications will be categorized based on the Clavien-Dindo classification system
Post-operative pain as measured by Visual analog scale (VAS)
The VAS is a valid and reliable method for quantifying pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain possible.
Sponsors and contacts
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