Status:
WITHDRAWN
LithoVue Elite Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Kidney Stone
Urolithiasis
Eligibility:
All Genders
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 El...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05201456
Start Date
April 1 2023
End Date
December 1 2023
Last Update
December 18 2023
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