Kidney Stone
Conditions
Keywords
ureteroscopy, lithovue, nephrolithiasis, single use 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.
Interventions
DEVICEsingle-use flexible digital ureteroscope
Device being tested.
DEVICEReusable Ureteroscope
Comparative device.
Sponsors
Boston Scientific Corporation
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free status | 6-10 weeks | Overall kidney stone burden that remains post ureteroscopy (if any) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| Maintenance and Repair | Through study completion, an average of 8 months | number of cases until repair (reusable scope), |
| Secondary procedures and/or unanticipated clinical events | 4-6 weeks post operatively | Includes adjuvant procedures and unscheduled hospital visits |
Countries
Canada, United States
Outcome results
None listed