Status: enrolling
CIRSE Registry for Emprint Microwave Ablation
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 will gather 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 will be 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.
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
- Economic aspects
Patient enrolment
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.
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 | VU Medisch Centrum/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 |