Michalot, Adrien
Bazin, Jean-Étienne
Richebé, Philippe
Allaouchiche, Bernard
Boselli, Emmanuel http://orcid.org/0000-0002-4949-3518
Funding for this research was provided by:
APICIL (1222.18)
Article History
Received: 22 September 2021
Accepted: 2 April 2022
First Online: 25 April 2022
Declarations
:
: The protocol, information leaflet, and consent form were submitted to the Sud-Est IV Ethics Committee (EC) for approval. Notification of the favorable decision of the EC was sent to the study sponsor and ANSM (French National Agency for the Safety of Medicines and Health Products). This favorable decision was dated 13 March 2018.The patients will be informed accurately and in full, in understandable terms, of the study objectives and constraints, any risks encountered, essential monitoring and safety measures, and their rights to refuse to participate in the study or to withdraw their consent at any time. The investigator must also inform the subjects of the decision reached by the ethics committee. Information on the study will be presented verbally and in writing the day before the procedure, during the pre-anesthetic visit. The patient’s written consent will be obtained once the investigator has outlined the study and has answered all of the patient’s questions.All of this information will be included in an information leaflet and consent form given to the patient. The patient’s voluntary, informed, written consent will be obtained by the investigator. These documents are approved by the competent ethics committee and are to be used for the trial in question, disregarding any other document. Two original copies will be signed jointly by the investigating physician and the patient. One copy will be given to the patient, and the second copy will be kept in the patient’s medical record.
: Not applicable
: EB has received travel grants and honoraria from MDoloris Medical Systems. The other authors declare that they have no competing interests.