Kidney StoneLVENCT05201456
LithoVue Elite Registry
An observational study of Kidney Stone and Urolithiasis, run by Boston Scientific Corporation.
Trial summary
To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Stone, Urolithiasis
- What is being tested?
- LithoVue Elite System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Dec 2023
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 250 subjects will be enrolled at approximately 11 sites globally
Who may be able to join
- Subject intends to undergo diagnostic and/or therapeutic procedure in the urinary tract with Boston Scientific LithoVue Elite System
- Subject is able to accurately detect and report pain
- Subject is willing and able to complete subject questionnaire at specified time points
- Subject is willing and able to return for all follow-up visits
Who cannot join
- Subject meets any of the contraindications per LithoVue Elite System Instructions/Directions for Use (IFU/DFU)
- Subject meets any of the contraindications per any accessory devices that will be used in the ureteroscopy procedure
- Investigator deems subject not suitable for the study
About this study
Official title: LithoVue Elite (LVE) Registry
To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.
Read the detailed description
LithoVue Elite Registry is a post-market, multi-center, open label, non-randomized, prospective study to document the safety and efficacy data on Boston Scientific LithoVue™ Elite System.
LithoVue Elite System, includes the StoneSmart™ Connect Console (reusable capital/workstation) and a single-use, disposable ureteroscope device.
The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
This is a post-market registry study. Any subject who meets eligibility criteria, intends to undergo a diagnostic and/or therapeutic procedure utilizing the LithoVue Elite System, and is willing to provide written informed consent, will be approached and considered for enrollment in the study. Data from diagnostic/therapeutic ureteroscopy procedure and standard of care post-ureteroscopy follow-up visits will be collected. These standard of care follow-up visits are expected to be scheduled within 120 days of the ureteroscopic procedure.
- Conditions
- Kidney Stone, Urolithiasis
- Being tested
- LithoVue Elite System
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithoVue Elite SystemDevice
The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
| Study group | Role | What they receive |
|---|---|---|
| Pressure Monitoring | Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite pressure monitoring single use flexible scope, real-time pressure monitoring technology, which will provide surgeons with intraluminal pressure data in the kidneys and ureter. Receives: Device: LithoVue Elite System | |
| Non-Pressure Monitoring | Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope. Receives: Device: LithoVue Elite System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
Primary safety end point is the occurrence of Serious Adverse Device Effects (SADE) related to the LithoVue Elite System including, but not limited to urinary tract perforation and ureteral avulsion
Measured: Up to 120 days of follow up
Technical Success using LithoVue Elite System - Primary Effectiveness Endpoint
Primary effectiveness endpoint is the technical success using LithoVue Elite System, defined as:
- Scope allows access to intended urinary anatomy (including utilization of active deflection and guidewire or access sheath)
- Scope allows diagnostic and therapeutic tools, as identified in product labelling, to be utilized at target area, if applicable
- Scope provides sufficient imaging for target visualization, (stone, calyx, etc.)
- Scope provides real-time urinary system pressure measurements at target sites, if applicable
Tool used will be a yes or no question on the case report form
Measured: Procedure
Secondary outcomes (1)
Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint
Secondary safety endpoint is the occurrence of Procedure-related adverse events and/or adverse device effects related to the LithoVue Elite System
Measured: Up to 120 days of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Dec 2023
Why it stopped: Business decision
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 Boston Scientific CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Chew, Principal investigator, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201456
- Sponsor's protocol ID
- U0701
- Acronym
- LVE
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2021
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LithoVue Elite (LVE) Registry
- ClinicalTrials.gov ID
- NCT05201456
- Acronym / sponsor ID
- LVE / U0701
- Conditions
- Kidney Stone, Urolithiasis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Jan 2022 (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.
To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.
Detailed description
LithoVue Elite Registry is a post-market, multi-center, open label, non-randomized, prospective study to document the safety and efficacy data on Boston Scientific LithoVue™ Elite System.
LithoVue Elite System, includes the StoneSmart™ Connect Console (reusable capital/workstation) and a single-use, disposable ureteroscope device.
The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
This is a post-market registry study. Any subject who meets eligibility criteria, intends to undergo a diagnostic and/or therapeutic procedure utilizing the LithoVue Elite System, and is willing to provide written informed consent, will be approached and considered for enrollment in the study. Data from diagnostic/therapeutic ureteroscopy procedure and standard of care post-ureteroscopy follow-up visits will be collected. These standard of care follow-up visits are expected to be scheduled within 120 days of the ureteroscopic procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Monitoring | – | Device: LithoVue Elite SystemSubjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite pressure monitoring single use flexible scope, real-time pressure monitoring technology, which will provide surgeons with intraluminal pressure data in the kidneys and ureter. |
| Non-Pressure Monitoring | – | Device: LithoVue Elite SystemSubjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 250 subjects will be enrolled at approximately 11 sites globally
Key inclusion criteria (4 listed)
- Subject intends to undergo diagnostic and/or therapeutic procedure in the urinary tract with Boston Scientific LithoVue Elite System
- Subject is able to accurately detect and report pain
- Subject is willing and able to complete subject questionnaire at specified time points
- Subject is willing and able to return for all follow-up visits
Key exclusion criteria (3 listed)
- Subject meets any of the contraindications per LithoVue Elite System Instructions/Directions for Use (IFU/DFU)
- Subject meets any of the contraindications per any accessory devices that will be used in the ureteroscopy procedure
- Investigator deems subject not suitable for 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 |
|---|---|---|
| LithoVue Elite SystemThe LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. | Device | Non-Pressure Monitoring, Pressure Monitoring |
Primary outcome
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
Time frame: Up to 120 days of follow up
Primary safety end point is the occurrence of Serious Adverse Device Effects (SADE) related to the LithoVue Elite System including, but not limited to urinary tract perforation and ureteral avulsion
Technical Success using LithoVue Elite System - Primary Effectiveness Endpoint
Time frame: Procedure
Primary effectiveness endpoint is the technical success using LithoVue Elite System, defined as: * Scope allows access to intended urinary anatomy (including utilization of active deflection and guidewire or access sheath) * Scope allows diagnostic and therapeutic tools, as identified in product labelling, to be utilized at target area, if applicable * Scope provides sufficient imaging for target visualization, (stone, calyx, etc.) * Scope provides real-time urinary system pressure measurements at target sites, if applicable Tool used will be a yes or no question on the case report form
1 secondary outcome
Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint
Time frame: Up to 120 days of follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Kidney Stone
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Kidney Stone, Nephrolithiasis
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
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 Chew principal investigator
Vancouver General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Urolithiasis, run by Boston Scientific Corporation.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint (time frame: Up to 120 days of follow up). The study lists 2 primary outcomes in all. 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 18 Dec 2023.