LithoVue Single Use Disposable Ureteroscope

Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Device: Reusable Ureteroscope; Device: single-use flexible digital ureteroscope

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • University of British Columbia
• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Eye and Ear Institute - Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reusable Ureteroscope; Standard ureteroscope.	Device: Reusable Ureteroscope; Comparative device.
Experimental: single-use flexible digital ureteroscope (LithoVue); Disposable ureteroscope being tested.	Device: single-use flexible digital ureteroscope; Device being tested.; Other Names: LithoVue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free status	Overall kidney stone burden that remains post ureteroscopy (if any)	6-10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Maintenance and Repair	number of cases until repair (reusable scope),	Through study completion, an average of 8 months
Secondary procedures and/or unanticipated clinical events	Includes adjuvant procedures and unscheduled hospital visits	4-6 weeks post operatively

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Ben H Chew, MD, University of British Columbia, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: nephrolithiasis; ureteroscopy; lithovue; single use ureteroscope
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID Numbers: H16-02436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes