Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
Purpose
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.
Conditions
- Kidney Stone
- Nephrolithiasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center
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.