LithoVue Single Use Disposable Ureteroscope
Primary Purpose
Kidney Stone
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
single-use flexible digital ureteroscope
Reusable Ureteroscope
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring ureteroscopy, lithovue, nephrolithiasis, single use ureteroscope
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.
Sites / Locations
- Eye and Ear Institute - Department of Urology
- University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Reusable Ureteroscope
single-use flexible digital ureteroscope (LithoVue)
Arm Description
Standard ureteroscope.
Disposable ureteroscope being tested.
Outcomes
Primary Outcome Measures
Stone-free status
Overall kidney stone burden that remains post ureteroscopy (if any)
Secondary Outcome Measures
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)
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.
Maintenance and Repair
number of cases until repair (reusable scope),
Secondary procedures and/or unanticipated clinical events
Includes adjuvant procedures and unscheduled hospital visits
Full Information
NCT ID
NCT03419091
First Posted
January 8, 2018
Last Updated
May 16, 2022
Sponsor
University of British Columbia
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03419091
Brief Title
LithoVue Single Use Disposable Ureteroscope
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
ureteroscopy, lithovue, nephrolithiasis, single use ureteroscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reusable Ureteroscope
Arm Type
Active Comparator
Arm Description
Standard ureteroscope.
Arm Title
single-use flexible digital ureteroscope (LithoVue)
Arm Type
Experimental
Arm Description
Disposable ureteroscope being tested.
Intervention Type
Device
Intervention Name(s)
single-use flexible digital ureteroscope
Other Intervention Name(s)
LithoVue
Intervention Description
Device being tested.
Intervention Type
Device
Intervention Name(s)
Reusable Ureteroscope
Intervention Description
Comparative device.
Primary Outcome Measure Information:
Title
Stone-free status
Description
Overall kidney stone burden that remains post ureteroscopy (if any)
Time Frame
6-10 weeks
Secondary Outcome Measure Information:
Title
Case completion with one scope
Description
Was the operation able to be completed with a single scope (did the scope break and/or did another one have to be used)
Time Frame
Day of procedure
Title
Scope optics (visual quality of the image provided by the scope)
Description
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.
Time Frame
Day of procedure
Title
Maintenance and Repair
Description
number of cases until repair (reusable scope),
Time Frame
Through study completion, an average of 8 months
Title
Secondary procedures and/or unanticipated clinical events
Description
Includes adjuvant procedures and unscheduled hospital visits
Time Frame
4-6 weeks post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben H Chew, MD
Organizational Affiliation
University of British Columbia, Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye and Ear Institute - Department of Urology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
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LithoVue Single Use Disposable Ureteroscope
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