Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Jane Ledesma
jledesma2@kumc.edu
19135888721
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center