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Article History

Received: 29 June 2021

Accepted: 5 July 2022

First Online: 2 September 2022

Declarations

:

: This trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practice Guidelines (ICH-GCP) [CitationRef removed], the European Directive on medical devices 93/42/EEC and the ISO Norm 14155 [CitationRef removed], and all applicable Swiss laws. The study has been approved by the relevant ethics committees: <i>Commission cantonale d’éthique de la recherche du Canton de Genève; Commission cantonale d'éthique de la recherche sur l'être humain du Canton de Vaud.</i> No 2019-01688<i>.</i> The trial was registered with the U.S. National Institutes of Health (ExternalRef removed, NCTNCT04745520),Study’s candidates receive an approved information sheet and a consent form describing the study and providing enough information for to make an informed decision about their participation in the study. Information includes the nature of study, its purpose, the procedures, the expected duration, and the potential risks and benefits. Permission is asked to use medical data for research purposes. The principal investigator or his delegate is available to answer questions. The candidates have a 1-day or overnight deadline to decide to participate or not.

: Not applicable

: The authors declare that they have no competing interests. The study is conducted in total independence from the medical device manufacturers.