LithoVue Single Use Disposable Ureteroscope

N/AUnknownNCT03419091

University of British Columbia40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Stone

Interventions

single-use flexible digital ureteroscopeDEVICE

Device being tested.

Reusable UreteroscopeDEVICE

Comparative device.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (2)

Eye and Ear Institute - Department of Urology

Columbus, Ohio, United States

University of British Columbia

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Stone-free status

Overall kidney stone burden that remains post ureteroscopy (if any)

Time frame: 6-10 weeks

Secondary Outcomes

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)

Time frame: 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.

Time frame: Day of procedure

Maintenance and Repair

number of cases until repair (reusable scope),

Time frame: Through study completion, an average of 8 months

Secondary procedures and/or unanticipated clinical events

Includes adjuvant procedures and unscheduled hospital visits

Time frame: 4-6 weeks post operatively

Data from ClinicalTrials.gov

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