Steinhauser, Stephan http://orcid.org/0009-0004-6234-4076
Ganter, Michael Thomas
Stadelmann, Vincent
Hofer, Christoph Karl
,
Article History
Received: 29 September 2023
Accepted: 31 October 2023
First Online: 28 November 2023
Declarations
:
: All authors declare that they have no competing interests.
: Ethical approval was obtained from the ethic committee Zurich (Kantonale Ethikkommission Zürich – KEK), BASEC-ID 2021–00074, the ethic committee Eastern Switzerland (Ethikkommission Ostschweiz – EKO) and the ethic committee Northwest – Central Switzerland (Ethikkommission Nordwest-Zentralschweiz – EKNZ). Each patient participating provided physical written informed consent before inclusion. A study code was allocated to each patient and any personal patient information is being stored separately from anonymized data. All data were handled according to the Swiss Data Protection Act. The study was performed in accordance with the Helsinki Declaration. Good clinical practice regarding the use of medical products was followed according to the European Guideline for medical products (93/42/EGW; MDR 2017/745) and ISO 14971. Safety procedures were applied as required (ClinO Art 37–43; ICH/E6 6.8; ISO14155 8.2.5., A.14.