Kidney StoneNCT03419091
LithoVue Single Use Disposable Ureteroscope
A study testing single-use flexible digital ureteroscope and Reusable Ureteroscope in people with Kidney Stone, run by University of British Columbia at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- single-use flexible digital ureteroscope and Reusable Ureteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2017to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Eye and Ear Institute - Department of Urology
Columbus, Ohio, 43212
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
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
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.
Read the 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
- Being tested
- single-use flexible digital ureteroscope, Reusable Ureteroscope
- Keywords
- ureteroscopy, lithovue, nephrolithiasis, single use ureteroscope
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-use flexible digital ureteroscopeDevice
Also called LithoVue
Device being tested.
Reusable UreteroscopeDevice
Comparative device.
| Study group | Role | What they receive |
|---|---|---|
| Reusable Ureteroscope | Active comparator | Standard ureteroscope. Receives: Device: Reusable Ureteroscope |
| single-use flexible digital ureteroscope (LithoVue) | Experimental | Disposable ureteroscope being tested. Receives: Device: single-use flexible digital ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free status
Overall kidney stone burden that remains post ureteroscopy (if any)
Measured: 6-10 weeks
Secondary outcomes (4)
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)
Measured: Day of procedure
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.
Measured: Day of procedure
Maintenance and Repair
number of cases until repair (reusable scope),
Measured: Through study completion, an average of 8 months
Secondary procedures and/or unanticipated clinical events
Includes adjuvant procedures and unscheduled hospital visits
Measured: 4-6 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Dec 2017
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben H Chew, MD, Principal investigator, University of British Columbia, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419091
- Sponsor's protocol ID
- H16-02436
- Status last verified
- May 2022
- First submitted
- 8 Jan 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03419091
- Acronym / sponsor ID
- H16-02436
- Conditions
- Kidney Stone
- Keywords
- ureteroscopy, lithovue, nephrolithiasis, single use ureteroscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reusable Ureteroscope | Active comparator | Device: Reusable UreteroscopeStandard ureteroscope. |
| single-use flexible digital ureteroscope (LithoVue) | Experimental | Device: single-use flexible digital ureteroscopeDisposable ureteroscope being tested. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-use flexible digital ureteroscopeAlso: LithoVueDevice being tested. | Device | single-use flexible digital ureteroscope (LithoVue) |
| Reusable UreteroscopeComparative device. | Device | Reusable Ureteroscope |
Primary outcome
Stone-free status
Time frame: 6-10 weeks
Overall kidney stone burden that remains post ureteroscopy (if any)
4 secondary outcomes
Case completion with one scope
Time frame: Day of procedure
Scope optics (visual quality of the image provided by the scope)
Time frame: Day of procedure
Maintenance and Repair
Time frame: Through study completion, an average of 8 months
Secondary procedures and/or unanticipated clinical events
Time frame: 4-6 weeks post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Related trials for Kidney Stone
RecruitingEarly Phase 1
Fecal Microbiota Transplantation in Kidney Stone Patients
Kidney Stones, Urinary Stone Disease / Nephrolithiasis
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Kidney Stone, Nephrolithiasis
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben H Chew, MD principal investigator
University of British Columbia, Associate Professor
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-use flexible digital ureteroscope and Reusable Ureteroscope in people with Kidney Stone, run by University of British Columbia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free status (time frame: 6-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022; AzTrials last refreshed its copy on 28 Oct 2026.