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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • INTRARENAL PRESSURE MONITORING VISIBLE

    Device

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: URS WITH INTRARENAL PRESSURE MONITORING VISIBLEActive comparator 1 intervention
Group B: URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLENo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Procedure

Secondary outcomes

1

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.

Time frame
Procedure
2

Post-operative infection

Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture

Time frame
30-days post-operative
3

Perioperative patient outcomes as measured by Clavien-Dindo classification system

Intraoperative complications will be categorized based on the Clavien-Dindo classification system

Time frame
Up to 30 days
4

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.

Time frame
Immediately post-operative and up to 7 days

Other outcomes

Sponsors and contacts

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