CIrse Emprint Microwave Ablation Registry
CIEMAR
Status: in follow-up
With CIEMAR the society plans to close the existing gap in real-life evidence regarding percutaneous microwave ablation for the treatment of liver metastases.
CIEMAR will be a large-scale data collection on microwave ablation in Europe that will have the chance to further the treatment's position in guidelines.
Study summary
CIEMAR is a European-wide, prospective, observational (non-interventional) study that gathers data on microwave ablation of colorectal liver metastases using the EMPRINT 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 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.
Endpoints
Primary endpoint
- Local tumour control 12 months after treatment on a per lesion basis
Secondary endpoints
- Safety
- 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
Patient enrolment
Patient inclusion started in September 2019 and ended in January 2023. CIEMAR has reached 500 patients and at the moment, patient follow-up data is being collected from 30 hospitals across 11 countries. Follow-up data will continue to be collected until January 2026.
Steering Committee
| Name | Hospital |
|---|---|
| Phillipe 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 University Hospital/NO |
| Nahum Goldberg | Hadassah Medical Center/IL |
| Thomas Helmberger | Städtisches Klinikum München/DE |
| Martijn Meijerink | University Medical Center Amsterdam/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 |
Publications
Pereira, P.L., Bale, R., Fretland, Å.A. et al. Local Tumour Control Following Microwave Ablation: Protocol for the Prospective Observational CIEMAR Study. Cardiovasc Intervent Radiol (2023). https://doi.org/10.1007/s00270-023-03573-0