LithoVue Single Use Disposable Ureteroscope

Kidney Stone Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03419091
• Other study ID #: H16-02436
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Device:
• single-use flexible digital ureteroscope
Device being tested.
• Reusable Ureteroscope
Comparative device.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	Eye and Ear Institute - Department of Urology	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone-free status	Overall kidney stone burden that remains post ureteroscopy (if any)	6-10 weeks
Secondary	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
Secondary	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
Secondary	Maintenance and Repair	number of cases until repair (reusable scope),	Through study completion, an average of 8 months
Secondary	Secondary procedures and/or unanticipated clinical events	Includes adjuvant procedures and unscheduled hospital visits	4-6 weeks post operatively