LithoVue Single Use Disposable Ureteroscope

NCT ID: NCT03419091

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2023-12-30

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.

Conditions

Kidney Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reusable Ureteroscope

Standard ureteroscope.

Group Type: ACTIVE_COMPARATOR

Reusable Ureteroscope

Intervention Type: DEVICE

Comparative device.

single-use flexible digital ureteroscope (LithoVue)

Disposable ureteroscope being tested.

Group Type: EXPERIMENTAL

single-use flexible digital ureteroscope

Intervention Type: DEVICE

Device being tested.

Interventions

single-use flexible digital ureteroscope

Device being tested.

Intervention Type: DEVICE

Reusable Ureteroscope

Comparative device.

Intervention Type: DEVICE

Other Intervention Names

LithoVue

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ben Chew, MD

Associate Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben H Chew, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, Associate Professor

Locations

Eye and Ear Institute - Department of Urology

Columbus, Ohio, United States

University of British Columbia

Vancouver, British Columbia, Canada

Countries

United States; Canada

Other Identifiers

H16-02436

Identifier Type: -

Identifier Source: org_study_id