Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
The CIRSE Emprint Microwave Ablation Registry (CIEMAR) is collecting real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System (full study duration) or Emprint HP Microwave Ablation System (from 2021 onwards). CIEMAR is a prospective, single-arm, multi-centre observational (non-interventional) study with the objective to observe the "real-life" use of MWA in Europe. The study is observing the use of the Emprint or Emprint HP Microwave Ablation System and all patients included in CIEMAR are receiving treatment with this device as their standard care for CRLM. Primary endpoint: local tumour control in liver at 12 months after MWA on a per lesion basis Secondary endpoints: Safety; Overall survival; Overall disease-free survival; Hepatic disease-free survival; Time to untreatable progression by thermal ablation; Systemic cancer therapy vacation; Quality of life; Adverse events and toxicity In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with MWA, CIEMAR is collecting quality of life data using the EORTC QLQ-C30 questionnaire. Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The patient will be offered to fill out the questionnaire in his/her mother tongue. The site and patient recruitment is complete with 500 patients from 30 sites across 11 European countries. The registry is currently collecting follow-up data (until January 2026).
Study Type
OBSERVATIONAL
Enrollment
500
Microwave Ablation of colorectal liver metastases
Local Tumor Control
Local Tumor Control at 12 months on a per lesion basis
Time frame: 12 months
Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE
Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.
Time frame: 3 years
Overall survival
Time from observation until death due to any cause (or censoring)
Time frame: 3 years
Overall disease-free-survival
Time from observation until disease progression or death assessed by the investigators
Time frame: 3 years
Hepatic disease-free-survival
Time from observation until disease progression in the liver or death assessed by the investigators.
Time frame: 3 years
Time to untreatable progression by thermal ablation
Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.
Time frame: 3 years
Systemic cancer therapy vacation
Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.
Time frame: 3 years
Treatment specific quality of life
Treatment specific quality of life will be assessed using the EORTC-QLQ-C30 questionnaire which includes 28 questions on a scale of 1 to 4 where 1 indicates lower impact of the disease on the patient's quality of life and 4 represents a high impact. Additionally 2 questions using a scale form 1 to 7 are used to generally assess the patient's quality of life where 1 represents poor quality of life and 7 represents an excellent quality of life.
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University Hospital Centre Sisters of Mercy
Zagreb, Croatia
Aarhus University Hospital
Aarhus, Denmark
University Hospital of Nimes
Nîmes, France
CHU de Reims
Reims, France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
DRK Kliniken Berlin Westend
Berlin, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
...and 28 more locations
Time frame: 1 year