Kantonsspital St.Gallen
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BIOMASTER BIOMONITOR III

Peter Ammann, Michaela Gemperle & Irene Schneider

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 ongoing - follow up
start of project 2020
end of project 2022
study design post-market clinical follow-up (PMCF) study
responsible person Peter Ammann