Clinical trial NCT03419091: LithoVue Single Use Disposable Ureteroscope
Official title: Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stone
Keywords: ureteroscopy
lithovue
nephrolithiasis
single use ureteroscope
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2018-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stone-free status
timeFrame: 6-10 weeks
Secondary outcomes:
measure: Case completion with one scope
timeFrame: Day of procedure
measure: Scope optics (visual quality of the image provided by the scope)
timeFrame: Day of procedure
measure: Maintenance and Repair
timeFrame: Through study completion, an average of 8 months
measure: Secondary procedures and/or unanticipated clinical events
timeFrame: 4-6 weeks post operatively
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Eye and Ear Institute - Department of Urology
state: Ohio
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia, Associate Professor
name: Ben H Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: