Carrero-Cardenal, Enrique http://orcid.org/0000-0003-3826-5277
Vollmer-Torrubiano, Ivan
Torres-López, Marta
Martín-Barrera, Gloria
Casanovas-Mateu, Georgina
Tercero-Machin, Francisco-Javier
Paez-Carpio, Alfredo
Fábregas-Julià, Neus
Valero-Castell, Ricard
Funding for this research was provided by:
Instituto de Salud Carlos III (PI12/01223)
Article History
Received: 14 February 2024
Accepted: 13 May 2024
First Online: 20 June 2024
<!--Emphasis Type='Bold' removed-->Declarations
:
: Ethical approval (HCP/2013/159) was granted by the Clinical Research Ethics Committee of the Hospital Clinic Barcelona, Barcelona, Spain (Chairperson Dr. X. Carné Cladellas) on 16 September 2013. The study was authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) on 24 March 2014 and registered at ClinicalTrials.gov (NCT02117908) on 11 April 2014. The study was conducted in accordance with the Declaration of Helsinki, and written informed consent was obtained from all patients.
: The authors declare no competing interests.
: The patient provided written consent for the use of medical images (Fig. ).
: This study aimed to investigate the safety of medical devices for new indications. The study was a complex research project spanning 4 years and involved real-time data acquisition and analysis of monitoring variables. The project required the expertise of multiple individuals from different disciplines and institutions, including clinicians, researchers, and statisticians from interventional radiology, anaesthesiology, nursing, the Institute for Biomedical Research August Pi i Sunyer (IDIBAPS), the Centre for Biomedical Research in the Respiratory Diseases Network (CIBERES), and the Clinical Quality and Safety Directorate of our hospital.