Bayer, Thomas A. http://orcid.org/0000-0003-1616-0714
Liu, Yanchen http://orcid.org/0009-0006-4471-1420
Vishnepolskiy, Igor http://orcid.org/0009-0001-3623-324X
Baez, Day http://orcid.org/0009-0005-3997-5926
Sanders, Lisbeth http://orcid.org/0009-0006-7794-4247
Williams, Rebecca http://orcid.org/0009-0000-3766-4298
Sanders, Jeff http://orcid.org/0009-0001-8742-7124
Serpico, Anthony http://orcid.org/0009-0007-6915-7005
Gravenstein, Stefan http://orcid.org/0000-0001-6000-6859
Article History
Received: 31 January 2024
Accepted: 3 July 2024
First Online: 23 September 2024
Declarations
:
: Advarra provided Institutional Review Board (IRB) approval and oversight of all study materials and procedures through a reliance agreement with the Rhode Island Hospital IRB. Advarra complies with US federal regulations and the ethical principles of the Belmont Report, the Nuremberg Code, and the Declaration of Helsinki. The Advarra IRB approved this study on August 24, 2022, protocol number Pro00062144. All participants or their legally-authorized representative provided written informed using an IRB-approved Informed Consent Form.
: Not applicable.
: Lisbeth Sanders, Lisbeth Sanders, Rebecca Williams, and Anthony Serpico have a commercial interest in the development and commercialization of the prototype that was tested in this study. The remaining authors have no competing interest.