LithoVue Elite Registry

Study Overview
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Brief Summary
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To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.

Detailed Description
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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.

Official Title
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LithoVue Elite (LVE) Registry

Conditions
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Kidney Stone, Urolithiasis

Intervention / Treatment
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* Device: LithoVue Elite System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pressure Monitoring<br>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. | Device: LithoVue Elite System<br>* 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.<br>|
| Non-Pressure Monitoring<br>Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope. | Device: LithoVue Elite System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 120 days of follow up |