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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06576661
Status
Recruiting
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Conditions

  • Kidney Stone
  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • INTRARENAL PRESSURE MONITORING VISIBLE — DEVICE
    In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.

Study Details

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.

Key Dates

Start date
Jan 28, 2025
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Jane Ledesma, BS
[email protected]
913-588-8721

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By research site
University of Kansas Medical Center· Kansas City, KS

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