Sconza, Cristiano http://orcid.org/0000-0002-5345-9902
Romano, Dario
Scaturro, Dalila
Mauro, Giulia Letizia
Leonardi, Giulia
Alito, Angelo
Respizzi, Stefano
Kon, Elizaveta
Di Matteo, Berardo
Article History
Received: 15 December 2023
Accepted: 18 January 2024
First Online: 12 February 2024
Declarations
:
: Cristiano Sconza, Dario Romano, Dalila Scaturro, Giulia Letizia Mauro, Giulia Leonardi, Angelo Alito, Stefano Respizzi, Elizaveta Kon, and Berardo Di Matteo declare no conflict of interest.
: The study was approved by the Humanitas University Ethical Committee and Institutional Review Board on 11 November 2021 (authorization number 3086). The study was conducted according to the Declaration of Helsinki, International Conference on Harmonization Good Clinical Practices, ISO 14155 (second edition), European Union Council Directive 93/42/EEC amended by 2007/47/EC, MEDDEV 2. 12–1 rev. 6 and amendments, and local legislation on clinical investigations involving medical devices. Patients provided their informed consent before study participation.