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Business decision
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To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Non-Pressure Monitoring | Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LithoVue Elite System | 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. |
| 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:
Tool used will be a yes or no question on the case report form | Procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Free Rate - Additional Endpoint | Stone clearance assessed by stone free rates (SFR), if applicable, at the follow-up visit | Up to 120 days of follow up |
| Surgeon Satisfaction with use of Scope - Additional Endpoint |
Inclusion Criteria:
Exclusion Criteria:
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Up to 250 subjects will be enrolled at approximately 11 sites globally
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| Name | Affiliation | Role |
|---|---|---|
| Ben Chew | Vancouver General Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Surgeon satisfaction on the use of scope will be measured on a 1-5 Likert scale
| Procedure |
| Post-operative Pain (Brief Pain Inventory (BPI)) - Additional Endpoint | Pain intensity and pain interference score on a scale of 0 to 10 as measured on the BPI | Discharge, 7 days post procedure and 30 days post procedure |
| Post-operative Infection - Additional Endpoint | Post-operative infection within 30 days of the procedure | Up to 30 days post procedure |
| Post-operative Systemic Inflammatory Response Syndrome (SIRS) - Additional Endpoint | 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 | Up to 30 days post procedure |
| Post-operative Quick Sepsis Related Organ Failure Assessment (qSOFA) - Additional Endpoint | 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 | Up to 30 days post procedure |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |