CIRSE Emprint Microwave Ablation Registry

Summary

Participation Requirements

Description

The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System. CIEMAR is a prospective, single-arm, multi-centre observational (non-interventional) study with th...

The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System. 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 will observe the use of the Emprint Microwave Ablation System and all patients included in CIEMAR will receive treatment with this device as their standard care for CRLM. Primary endpoint: local tumour control in liver at 12 months after the microwave ablation treatment on a per lesion basis Secondary objectives: 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; Economic aspects 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 will incorporate 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 registry is currently in design and it is planned to start patient inclusion in January 2020. The target is to enrol 1000 patients and patient enrolment will stop two years after the enrolment of the first patient. A follow-up period of three years has been defined by the CIEMAR Steering Committee.

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