Dowling, Gavin P.
Toomey, Sinead
Bredin, Philip
Parker, Imelda
Mulroe, Eibhlin
Marron, Jacinta
McLoughlin, Olivia
Teiserskiene, Ausra
Power, Colm
O’Shea, Anne Marie
Greally, Megan
Morris, Patrick G.
Duke, Deirdre
Hill, Arnold D. K.
Hennessy, Bryan T.
Article History
Received: 20 December 2023
Accepted: 6 January 2024
First Online: 17 January 2024
Declarations
:
: The trial protocol was approved by the National Office for Research Ethics Committee for Clinical Trials (NREC-CT), the NREC for Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices (NREC-MD), the Health Products Regulatory Authority (HPRA) and the HPRA Medical Devices (HPRA-MD). The trial was registered in the European drug regulatory affairs Clinical Trials database (Eudra-CT 2022–002485-32, June 30, 2022) and ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT05710666). This study is being conducted in accordance with the Good Clinical Practice guidelines and the guiding principles outlined in the Declaration of Helsinki. All prospective patients must provide written informed consent for participation in the study procedures. Before informed consent may be obtained, the investigator should provide the patient ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the patient. Patients are well informed that participation in voluntary and that they may withdraw at any point during the study. Informed consent includes consent for collection and use of biological specimens (i.e. blood and tissue). Written informed consent of patients is required before enrolment in the trial or study related procedures take place. All data are handled with strict confidentiality, assuring anonymity of patients.
: Not applicable.
: The authors declare that they have no competing interests.