Project

BIOMASTER BIOMONITOR III

Completed ยท 2020 until 2022

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2020
End Date
2022
Financing
Industry
Study Design
post-market clinical follow-up (PMCF) study
Brief description/objective

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.
Primary endpoint
SADE-free rate related to BIOMONITOR III including incision and insertion tool set until 3-month follow-up