LithoVue Single Use Disposable Ureteroscope

NCT03419091 | Unknown FDA Device

• 1 other identifier: H16-02436
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

Kidney Stone

Keywords

ureteroscopy; lithovue; nephrolithiasis; single use ureteroscope

Outcome Measures

Primary Outcomes (1)

• Stone-free status

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

  6-10 weeks

Secondary Outcomes (4)

• Case completion with one scope

  Day of procedure

• Scope optics (visual quality of the image provided by the scope)

  Day of procedure

• Maintenance and Repair

  Through study completion, an average of 8 months

• Secondary procedures and/or unanticipated clinical events

  4-6 weeks post operatively

Study Arms (2)

Reusable Ureteroscope

ACTIVE COMPARATOR

Standard ureteroscope.

Device: Reusable Ureteroscope

single-use flexible digital ureteroscope (LithoVue)

EXPERIMENTAL

Disposable ureteroscope being tested.

Device: single-use flexible digital ureteroscope

Interventions

single-use flexible digital ureteroscope DEVICE

Device being tested.

Also known as: LithoVue

single-use flexible digital ureteroscope (LithoVue)

Reusable Ureteroscope DEVICE

Comparative device.

Reusable Ureteroscope

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years or older and able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Eye and Ear Institute - Department of Urology

Columbus, Ohio, 43212, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben H Chew, MD

  University of British Columbia, Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 1, 2018
• Study Start: December 1, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

CA (1); US (1)