November 7th, we have received excellent news as LIVERATION study has been approved by the Research Ethics Committee from the Park de Salut MAR and is now ready to begin recruitment of patients with Primary Liver Cancer or Colorectal Cancer with Liver Metastasis patients in 5 out of the 24 clinical centers of the Study. The goal of the study is to recruit 720 patients across 7 different countries in Europe.
This means that the clinical study meets the highest ethical standards, following the provisions of EU Regulation 2017/745 of April 5, 2017 and Royal Decree 192/2023, of March 21, which regulates medical devices also. The Ethics committee has approved the Consent Form and the Recruitment plan as well and has considered that the Safety and Data Management are adequate. This should ensure a rapid extension of the trial to the other 6 different countries in the study (France, Poland, Slovenia, Italy, Greece and Switzerland).
Recruitment is expected to be initiated in November of 2023 through January 2024 at least in the 5 centers for which is has received the approval: Clinical University Hospital of Valencia, Reina Sofia University Hospital, HM Sanchinarro, Hospital Universitari de Girona and del Mar Hospital. We are eager to begin with the clinical trial as we really hope this project will bring a new perspective to Liver Cancer treatment and improve Cancer patients lives.