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Clinical Trial Summary

To obtain post-market safety and efficacy data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).


Clinical Trial Description

Multi-center, open label, prospective study to document on-going post-market safety and performance of Flexiva Pulse High Power Single-Use Laser Fibers. All subjects meeting the enrollment criteria, signing the consent and undergoing the lithotripsy/HoLEP procedure with the study device(s) will be followed: up to 2 months (60 days) post-discharge from final holmium laser lithotripsy procedure for subjects in the lithotripsy cohort or up to 6 months (180 days + 60 days) post discharge from HoLEP procedure for subjects in the Benign Prostatic Hyperplasia (BPH) cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05027971
Study type Observational [Patient Registry]
Source Boston Scientific Corporation
Contact Winnie Chen
Phone 952-930-6000
Email [email protected]
Status Not yet recruiting
Phase
Start date September 2021
Completion date May 2023

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