BIOMASTER BIOMONITOR III
| abstract |
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 |
| type of project | clinical studies |
| status | completed |
| start of project | 2020 |
| end of project | 2022 |
| study design | post-market clinical follow-up (PMCF) study |
| responsible person | Peter Ammann |