Stone, Kidney, UTI
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStorz Flex-XC1 Disposable Flexible Ureteroscope
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
DEVICEStorz Flexible Digital Ureteroscope
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Males and Females 18-89 undergoing ureteroscopy for laser treatment of renal calculi * Willing to sign the Informed Consent Form * Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
Exclusion criteria
* Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scope performance | 0-1 day | Difference in scope performance grading by multiple blinded reviewers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative outcomes | 4-6 weeks | The difference in postoperative outcomes using a questionnaire: the patient has a UTI |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution) | 4-6 weeks | 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) |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color) | 4-6 weeks | 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) |
| Operating room outcomes | 0-1 day | The difference in operating room outcomes: basketing time |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference | 4-6 weeks | 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) |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view | 4-6 weeks | 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) |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression | 4-6 weeks | 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) |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference | 4-6 weeks | 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) |
Countries
United States
Outcome results
None listed