CIRSE Emprint Microwave Ablation Registry
Status: in follow-up
CIEMAR is a European-wide, prospective, observational (non-interventional) study that is gathering data on microwave ablation of colorectal liver metastases using the Emprint or Emprint HP microwave ablation device. Microwave tumour ablation provides a minimally invasive, potentially curative treatment option for various neoplasms and has been in use for over 15 years. The safety and efficacy of CRLM ablation has been demonstrated in randomised trials but large and prospective real-life data on effectiveness of microwave ablation is still lacking.
Data is being collected prospectively from medical centres throughout Europe via an electronic data capture (EDC) system. The primary objective is to assess the effectiveness of microwave ablation performed with the Emprint or Emprint HP device in controlling colorectal metastatic tumours in the liver.
CIEMAR has been approved to collect data on the Emprint HP device which will be submitted as post-market clinical follow-up data under MDR by the relevant notified body.
In January 2023, patient enrolment was completed and CIEMAR reached its target of 500 patients. Follow-up data collection of enrolled patients will continue for three more years, until January 2026, to achieve the intended long-term follow-up period.
The CIRSE Emprint Microwave Ablation Registry is funded by a grant provided by Medtronic.
- Local tumour control 12 months after treatment on a per lesion basis
- Adverse events and toxicity
- Overall survival
- Overall disease-free survival
- Hepatic disease-free survival
- Time to untreatable progression by thermal ablation
- Systemic cancer therapy vacation
- Quality of life
- Economic aspects
Patient inclusion started in September 2019 and will continue until January 2023. At the moment data is being collected from 11 countries from a total of 24 hospitals. Follow-up information will be collected until January 2026.
|Philippe L. Pereira (Co-Chairperson)||SLK Kliniken Heilbronn/DE|
|Thierry de Baère (Co-Chairperson)||Institute Goustave Roussy/FR|
|Reto Bale||Universitätsklinik Innsbruck/AT|
|Åsmund A. Fretland||Oslo Universitetssykehus/NO|
|Nahum Goldberg||Hadassah Medical Center/IL|
|Thomas Helmberger||Städtisches Klinikum München/DE|
|Martijn Meijerink||Amsterdam UMC/NL|
|Franco Orsi||European Institute of Oncology Milan/IT|
|Theo Ruers||Cancer Institute of Amsterdam/NL|
|Stefan Stättner||Salzkammergut Klinikum Vöcklabruck/AT|
|Thomas Vogl||Universitätsklinik Frankfurt/DE|