Frederiksen, Bill Aplin
Schousboe, Maja
Terslev, Lene
Iversen, Nikolaj
Lindegaard, Hanne
Savarimuthu, Thiusius Rajeeth
Just, Søren Andreas http://orcid.org/0000-0002-3946-5919
Funding for this research was provided by:
Region of Southern Denmark ((21/17499)
Article History
Received: 17 February 2022
Accepted: 2 August 2022
First Online: 8 August 2022
Declarations
:
: All patients signed informed consent to participate. The study was first evaluated by the regional ethics committee (ID: S-20200145), which ruled it was not necessary for their approval. It was a quality assessment project where there was no intervention to the patient. The study was hereafter submitted to Odense University Hospital, Region of Southern Denmark as a quality assessment project and approved (ID: 20/55294). A data user and data handling agreement regarding this study between OUH and ROPCA Holding were signed 4/12-2020. The Danish Medicine Agency evaluated ARTHUR as not to applied as a new medical device, as all parts are CE approved and used as approved (ID: 2017123702).
: Not applicable.
: Employees of Ropca Holding were not involved in data analysis or in developing conclusions based on data. SAJ and TRS are cofounders of Ropca Holding. SAJ and TRS have received no salary or consultant fees from Ropca Holding.