Kidney Stone, Urolithiasis
Conditions
Brief summary
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.
Interventions
DEVICELithoVue 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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject intends to undergo diagnostic and/or therapeutic procedure in the urinary tract with Boston Scientific LithoVue Elite System 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
1. Subject meets any of the contraindications per LithoVue Elite System Instructions/Directions for Use (IFU/DFU) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint | Up to 120 days of follow up | Secondary safety endpoint is the occurrence of Procedure-related adverse events and/or adverse device effects related to the LithoVue Elite System |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Infection - Additional Endpoint | Up to 30 days post procedure | Post-operative infection within 30 days of the procedure |
| Stone Free Rate - Additional Endpoint | Up to 120 days of follow up | Stone clearance assessed by stone free rates (SFR), if applicable, at the follow-up visit |
| Post-operative Quick Sepsis Related Organ Failure Assessment (qSOFA) - Additional Endpoint | Up to 30 days post procedure | In subjects hospitalized post-procedure for infection, sepsis information based on Quick Sepsis Related Organ Failure Assessment (qSOFA) score will be collected, if available. Urinary sepsis will be defined as a qSOFA score ≥2 points |
| Post-operative Systemic Inflammatory Response Syndrome (SIRS) - Additional Endpoint | Up to 30 days post procedure | In subjects hospitalized post-procedure for infection, the complication will be characterized using the clinical measurements of the Systemic Inflammatory Response Syndrome (SIRS) score, if available. Subjects with a score ≥2 points meet the SIRS criteria |
| Surgeon Satisfaction with use of Scope - Additional Endpoint | Procedure | Surgeon satisfaction on the use of scope will be measured on a 1-5 Likert scale |
| Post-operative Pain (Brief Pain Inventory (BPI)) - Additional Endpoint | Discharge, 7 days post procedure and 30 days post procedure | Pain intensity and pain interference score on a scale of 0 to 10 as measured on the BPI |
Outcome results
None listed