LithoVue Single Use Disposable Ureteroscope | NCT03419091

Studies
LithoVue Single Use Disposable Ureteroscope

NCT03419091

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

May 17, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Kidney Stone

Interventions

single-use flexible digital ureteroscope
Reusable Ureteroscope

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Jan 8, 2018

First Submission Date that Met QC Criteria

Jan 25, 2018

First Posted Date

Feb 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ben Chew, MD, Associate Professor of Urology, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
single-use flexible digital ureteroscope	Device	Device being tested.	single-use flexible digital ureteroscope (LithoVue)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben H Chew, MD	University of British Columbia, Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye and Ear Institute - Department of Urology		Columbus	Ohio	43212	United States
University of British Columbia

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

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.

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.