NCT03775980

CIRSE Emprint Microwave Ablation Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Cardiovascular and Interventional Radiological Society of Europe · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.

Detailed description

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).

Conditions

• Colorectal Neoplasms Malignant
• Neoplasm Metastasis

Interventions

Type	Name	Description
DEVICE	Emprint Microwave Ablation System	Microwave Ablation of colorectal liver metastases

Timeline

• Start date: 2019-09-04
• Primary completion: 2023-01-03
• Completion: 2026-01-31
• First posted: 2018-12-14
• Last updated: 2026-02-11

Locations

38 sites across 13 countries: Croatia, Denmark, France, Germany, Greece, Italy, Lithuania, Netherlands, North Macedonia, Norway, Portugal, Spain, Turkey (Türkiye)