Seefeldt, C. S. http://orcid.org/0000-0002-6372-1273
Meyer, J. S. http://orcid.org/0000-0002-3757-2411
Knievel, J. http://orcid.org/0000-0002-6213-590X
Rieger, A. http://orcid.org/0000-0002-4145-5322
Geißen, R. http://orcid.org/0000-0002-6496-4613
Lefering, R. http://orcid.org/0000-0002-0141-1747
Heiss, M. M.
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (HE 1586/5-1)
Article History
Received: 25 April 2018
Accepted: 10 December 2018
First Online: 16 January 2019
Ethics approval and consent to participate
: This trial is conducted in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice and the Declaration of Helsinki.According to the German Medical Devices Act (MPG) the trial is classified as an exception to clinical investigations according to section 23b MPG. This is due to the fact that the investigational device is CE-marked, will only be used within its intended purpose and there will be no additional invasive examinations.Ethical approval of the Lead Ethical Committee, the Ethical Committee of the University of Witten/Herdecke, has been fully granted without any conditions on 4 July 2017. All participating centers obtained additional approval of their appropriate ethical committees. Written informed consent will be obtained from all participants prior to their participation.Any amendments will be submitted to all of the Ethical Committees.
: Not applicable.
: The authors declare that they have no competing interests.
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