Development of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure (ACLF)

Deliverables

Documents, reports (19)

project web site

Report on design and content of project web site

Supply and Train clinical teams at individual sites about the use of DIALIVE

Supply and Train clinical teams at individual sites about the use of DIALIVE.

Incorporation of the Albutec Hepalbin™ filter into DIALIVE

Incorporation of the Albutec Hepalbin™ filter into DIALIVE

'All approvals package' Contracts with relevant hospitals for the SAFETY clinical trial and for the EFFICACY trial

Also due at M24

'First study subject approvals package' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trial

Also due at M21 'First study subject approvals package' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trial

Results of models, and data visualisation, for predicting ACLF and efficacy of DIALIVE treatment

Also at M45

Clinical Trial Reports for the SAFETY and EFFICACY trial

Also due at M24

Packaging and labelling of the filters for delivery to clinical trial sites

Report on packaging and labeling of filters

Setting up the eCRFs and the associated database for the proposed SAFETY and EFFICACY clinical trials

Setting up the eCRFs and the associated database for the proposed SAFETY and EFFICACY clinical trials

Documentation and implementation of QMS per ISO 13485

Documentation and implementation of QMS per ISO 13485

Datamart logical data Model (data fusion) analysis of available data

Datamart logical data Model (data fusion) analysis of available data

Supply agreement for filters and purchase of Prismaflex for the different sites

Supply agreement for filters and purchase of Prismaflex for the different sites

Regulatory approval received for pre-CE mark Safety clinical trial and EFFICACY trial

Also due at M18 Details on regulatory approval received for gaining the pre-CE Mark SAFETY and EFFICACY trial

CE-mark for DIALIVE

Report on gaining CE mark for DIALIVE

Technical file and Design Dossier

report on Technical file and Design Dossier

Generation of Standard operating procedures and trouble shooting manual for DIALIVE

Generation of Standard operating procedures and trouble shooting manual for DIALIVE

Establish requirements of the datamart and data fusion

Establish requirements of the datamart and data fusion

Report of statistical visualizations from ALIVER datamart.

Also at M43

Statistical models using the data generated in the ALIVER trials.

Also at M42

Publications

Other (3)

EF-CLIF summary of activities 2019

Author(s): EF-CLIF
Published in: 2019
Publisher: EF-CLIF

EF-CLIF summary of activities 2018

Author(s): EF-CLIF
Published in: 2019
Publisher: EF-CLIF

EFCLIF Sumary of scientific activity 2020

Author(s): EF-CLIF
Published in: 2021
Publisher: EF-CLIF

Conference proceedings (1)

An Accurate Data Preparation Approach for the Prediction of Mortality in ACLF Patients using the CANONIC Dataset

Author(s): M. S. Garcia, Banwari Agarwal, Rajeshwar P. Mookerjee, Rajiv Jalan, Gordon Doyle, Gabriele Ranco, Vicente Arroyo, Marco Pavesi, Elizabet Garcia, Faouzi Saliba, Rafael Banares, Javier Fernandez
Published in: 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), 2019, Page(s) 1371-1377, ISBN 978-1-5386-1311-5
Publisher: IEEE
DOI: 10.1109/embc.2019.8857239