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Clinical Trial Summary

To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05201456
Study type Observational [Patient Registry]
Source Boston Scientific Corporation
Contact Reshma Rao
Phone 9529306000
Email [email protected]
Status Not yet recruiting
Phase
Start date May 2023
Completion date March 2024

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