Art

Reichweite

Bereiche

Status

Start

Ende

Finanzierungsart

Studiendesign

Kurzbeschreibung/Zielsetzung

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