Type

Range

Units

Status

Start Date

End Date

Financing

Study Design

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