Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-04-01
2023-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
LithoVue Elite System
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.
Non-Pressure Monitoring
Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope.
LithoVue Elite System
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.
Interventions
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LithoVue Elite System
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.
Eligibility Criteria
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Inclusion Criteria
2. Subject is able to accurately detect and report pain
3. Subject is willing and able to complete subject questionnaire at specified time points
4. Subject is willing and able to return for all follow-up visits
Exclusion Criteria
2. Subject meets any of the contraindications per any accessory devices that will be used in the ureteroscopy procedure
3. Investigator deems subject not suitable for the study
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ben Chew
Role: PRINCIPAL_INVESTIGATOR
Vancouver General Hospital
Other Identifiers
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U0701
Identifier Type: -
Identifier Source: org_study_id