Ethical Considerations
The study was conducted in compliance with the 1964 Declaration of Helsinki and later amendments, ISO 14155:2020, Medical Device Regulation (EU) 2017/745, and ICH-GCP E6. The study received approval on October 26, 2021, by the Comité de Protection des Personnes, Région Ouest, Ouest 1 (approval number 2021-A02358-33). All patients signed an informed consent form before inclusion and performing any study-related procedure. The study is registered at ClinicalTrials.gov under registration number NCT05172492.