LithoVue Single Use Disposable Ureteroscope

Study Overview
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Brief Summary
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Most flexible ureteroscopes that are used to treat kidney stones have been reusable. Recently, advances in technology have resulted in single-use (disposable) ureteroscopes to become available. The investigators are interested in determining if the performance of the two types of scopes are equivalent. This will help guide institutions in the future to purchase the best scopes for their patients.

Detailed Description
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Ureteroscopy is commonly used in the treatment of kidney stones. Flexible ureteroscopes are costly to purchase and repair. Issues with flexible ureteroscopes include loss of deflection and visual performance (fiberoptic pixels) with use and the high repair costs. Reprocessing and sterilization of reusable ureteroscopes also requires staff who are specially trained and dedicated in this area. Inadequate sterilization could also lead to transmissible infections between patients. A single-use flexible digital ureteroscope has recently become commercially available (LithoVue, Boston Scientific, Marlborough, MA). Pre-clinical testing show the accessibility to the ureter and all areas of the kidney to be equivalent to current flexible ureteroscopes. However, clinical data comparing this single-use ureteroscope to a current state of the art reusable ureteroscope is lacking. Establishing at least equivalence in performance between the new single use ureteroscope and a reusable digital ureteroscope will help surgeons and operating room managers/administrators help determine how to most efficiently equip their operating rooms with endoscopic equipment.

Official Title
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Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial

Conditions
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Kidney Stone

Intervention / Treatment
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* Device: single-use flexible digital ureteroscope
* Device: Reusable Ureteroscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm) 19 years or older and able to provide informed consent Exclusion Criteria: patients < 18 years pregnant patients with known nephrocalcinosis . any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a prospective, randomized clinical trial. Patients will be randomized 1:1 in randomization blocks of 4 to undergo the procedure with either the LithoVue single use flexible ureteroscope or the digital reusable flexible ureteroscope. Ureteroscopy will be performed using a standardized technique.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reusable Ureteroscope<br>Standard ureteroscope. | Device: Reusable Ureteroscope<br>* Comparative device.<br>|
| Experimental: single-use flexible digital ureteroscope (LithoVue)<br>Disposable ureteroscope being tested. | Device: single-use flexible digital ureteroscope<br>* Device being tested.<br>* Other names: LithoVue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone-free status | Overall kidney stone burden that remains post ureteroscopy (if any) | 6-10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Case completion with one scope | Was the operation able to be completed with a single scope (did the scope break and/or did another one have to be used) | Day of procedure | 
| Scope optics (visual quality of the image provided by the scope) | At the start and end of each procedure the surgeon will take a video clip of the intrarenal collecting system - these clips will then be evaluated and scored by blinded urologists.They will use a 5 point Likert scale that will evaluate the quality of the image in multiple categories from poor (1) to excellent (5) in multiple categories. Categories include: Focus/Sharpness, Exposure, Color Accuracy, and Overall Image Quality. | Day of procedure | 
| Maintenance and Repair | number of cases until repair (reusable scope), | Through study completion, an average of 8 months | 
| Secondary procedures and/or unanticipated clinical events | Includes adjuvant procedures and unscheduled hospital visits | 4-6 weeks post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteroscopy, lithovue, nephrolithiasis, single use ureteroscope