This study is designed to provide an evaluation of currently available disposable flexible ureteroscopes in real-world conditions. Due to high re-processing costs associated with re-usable flexible ureteroscopes, there has been a demand for Urologic device manufacturers to provide single-use flexible ureteroscopes.
Patients randomized to the experimental group will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope. Data will be collected and stored electronically in REDCap. Quality assurance steps will include testing of the database, including any potential data calculated by command functions within REDCap Scope performance survey will be administered with REDcap.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
Northwestern University
Chicago, Illinois, United States
Scope performance
Difference in scope performance grading by multiple blinded reviewers
Time frame: 0-1 day
Operating room outcomes
The difference in operating room outcomes: basketing time
Time frame: 0-1 day
Operating room outcomes
The difference in operating room outcomes: scope setup time
Time frame: 0-1 day
Operating room outcomes
The difference in operating room outcomes: laser-use time
Time frame: 0-1 day
Operating room outcomes
The difference in operating room outcomes: operative time
Time frame: 0-1 day
Operating room outcomes
The difference in operating room outcomes: number of flexible ureteroscopes used
Time frame: 0-1 day
Post-operative outcomes
The difference in postoperative outcomes using a questionnaire: the patient has a UTI
Time frame: 4-6 weeks
Post-operative outcomes
The difference in postoperative outcomes using a questionnaire: the patient is stone-free
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)
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Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Time frame: 4-6 weeks