Clinical trial NCT05201456: LithoVue Elite Registry
Official title: LithoVue Elite (LVE) Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Kidney Stone
Urolithiasis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 250 subjects will be enrolled at approximately 11 sites globally

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
timeFrame: Up to 120 days of follow up
measure: Technical Success using LithoVue Elite System - Primary Effectiveness Endpoint
timeFrame: Procedure
Secondary outcomes:
measure: Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint
timeFrame: Up to 120 days of follow up
Other outcomes:
measure: Stone Free Rate - Additional Endpoint
timeFrame: Up to 120 days of follow up
measure: Surgeon Satisfaction with use of Scope - Additional Endpoint
timeFrame: Procedure
measure: Post-operative Pain (Brief Pain Inventory (BPI)) - Additional Endpoint
timeFrame: Discharge, 7 days post procedure and 30 days post procedure
measure: Post-operative Infection - Additional Endpoint
timeFrame: Up to 30 days post procedure
measure: Post-operative Systemic Inflammatory Response Syndrome (SIRS) - Additional Endpoint
timeFrame: Up to 30 days post procedure
measure: Post-operative Quick Sepsis Related Organ Failure Assessment (qSOFA) - Additional Endpoint
timeFrame: Up to 30 days post procedure
Locations:
Study officials:
affiliation: Vancouver General Hospital
name: Ben Chew
role: PRINCIPAL_INVESTIGATOR
References: