Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi

Conditions
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UTI, Stone, Kidney

Intervention / Treatment
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* Device: Storz Flex-XC1 Disposable Flexible Ureteroscope
* Device: Storz Flexible Digital Ureteroscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Storz Flex-XC1 disposable flexible ureteroscope<br>A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. | Device: Storz Flex-XC1 Disposable Flexible Ureteroscope<br>* Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.<br>|
| No Intervention: Analogue scope<br>A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. | |
| Experimental: Digital ureteroscope<br>A patient is randomized to the experimental arm using a Digital ureteroscope. | Device: Storz Flexible Digital Ureteroscope<br>* Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scope performance | Difference in scope performance grading by multiple blinded reviewers | 0-1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating room outcomes | The difference in operating room outcomes: basketing time | 0-1 day | 
| Operating room outcomes | The difference in operating room outcomes: scope setup time | 0-1 day | 
| Operating room outcomes | The difference in operating room outcomes: laser-use time | 0-1 day | 
| Operating room outcomes | The difference in operating room outcomes: operative time | 0-1 day | 
| Operating room outcomes | The difference in operating room outcomes: number of flexible ureteroscopes used | 0-1 day | 
| Post-operative outcomes | The difference in postoperative outcomes using a questionnaire: the patient has a UTI | 4-6 weeks | 
| Post-operative outcomes | The difference in postoperative outcomes using a questionnaire: the patient is stone-free | 4-6 weeks | 
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution) | 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) | 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) | 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) | 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) | 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) | 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) | 4-6 weeks |