LithoVue Single Use Disposable Ureteroscope

Not Applicable

Interventions: Device: Reusable Ureteroscope
Device: single-use flexible digital ureteroscope

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Reusable Ureteroscope	Reusable Ureteroscope	Standard ureteroscope.
single-use flexible digital ureteroscope (LithoVue)	single-use flexible digital ureteroscope	Disposable ureteroscope being tested.

Primary Outcome Measures

Name	Time	Method
Stone-free status	6-10 weeks	Overall kidney stone burden that remains post ureteroscopy (if any)

Secondary Outcome Measures

Name	Time	Method
Secondary procedures and/or unanticipated clinical events	4-6 weeks post operatively	Includes adjuvant procedures and unscheduled hospital visits
Case completion with one scope	Day of procedure	Was the operation able to be completed with a single scope (did the scope break and/or did another one have to be used)
Maintenance and Repair	Through study completion, an average of 8 months	number of cases until repair (reusable scope),
Scope optics (visual quality of the image provided by the scope)	Day of procedure	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.

Locations (2): Eye and Ear Institute - Department of Urology
🇺🇸
Columbus, Ohio, United States
University of British Columbia
🇨🇦
Vancouver, British Columbia, Canada

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