LithoVue Single Use Disposable Ureteroscope

• Sponsor: University of British Columbia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03419091
• Collaborator: Boston Scientific Corporation (Industry)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 72.9
• Patients Per Site: 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Device: single-use flexible digital ureteroscope; Device: Reusable Ureteroscope	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Stone-free status [6-10 weeks]

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

Secondary Outcome Measures

1. Case completion with one scope [Day of procedure]

   Was the operation able to be completed with a single scope (did the scope break and/or did another one have to be used)

2. Scope optics (visual quality of the image provided by the scope) [Day of procedure]

   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.

3. Maintenance and Repair [Through study completion, an average of 8 months]

   number of cases until repair (reusable scope),

4. Secondary procedures and/or unanticipated clinical events [4-6 weeks post operatively]

   Includes adjuvant procedures and unscheduled hospital visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye and Ear Institute - Department of Urology	Columbus	Ohio	United States	43212
2	University of British Columbia	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

• University of British Columbia
• Boston Scientific Corporation

Investigators

• Principal Investigator: Ben H Chew, MD, University of British Columbia, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ben Chew, MD, Associate Professor of Urology, University of British Columbia
• ClinicalTrials.gov Identifier: NCT03419091
• Other Study ID Numbers: H16-02436
• First Posted: Feb 1, 2018
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ben Chew, MD, Associate Professor of Urology, University of British Columbia: ureteroscopy; lithovue; nephrolithiasis; single use ureteroscope
• Additional relevant MeSH terms: Kidney Calculi

Study Results

No Results Posted as of May 17, 2022