Status:
ACTIVE_NOT_RECRUITING
CIRSE Emprint Microwave Ablation Registry
Lead Sponsor:
Cardiovascular and Interventional Radiological Society of Europe
Collaborating Sponsors:
Medtronic
Conditions:
Colorectal Neoplasms Malignant
Neoplasm Metastasis
Eligibility:
All Genders
18-99 years
Brief 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 (...
Eligibility Criteria
Inclusion
- 18 years or older
- Proven colorectal liver metastases either histologically proven or diagnosed by imaging in a patient with known colorectal cancer
- Treated with the Emprint or Emprint HP Microwave ablation system
- Patient referred to MWA by a multidisciplinary tumour board
- Signed informed consent form
- Intention to completely treat (ablation, resection, SBRT) all visible disease within 8 weeks
- Maximum number of 9 total liver lesions
- All liver lesions must be local treatment-naive
- Maximum diameter of the largest liver lesion treated with MWA must not exceed 3cm
- Maximum diameter of lesions treated surgically may exceed this limitation
- Maximum number of 5 lung nodules eligible to be treated
- Patients may receive simultaneous liver resection and microwave ablation
- Patients may have received previous systemic therapy
- Patients must not have received surgical resection or thermal ablation for other liver lesions in the last 3 months before inclusion
- Patients treated with a liver-first approach may be included if treatment of the primary tumour is planned
- If applicable: complete response of treated rectal tumour proven by imaging
Exclusion
- Life expectancy less than 6 months (palliative treatment)
- Extrahepatic metastases with the exception of a maximum of 5 lung nodules
- Ongoing infection (viral/bacterial)
- Patients receiving simultaneous bowel surgery and microwave ablation
- Patients receiving simultaneous IRE, RFA, SBRT, Cryoablation, HIFU or other local treatment than resection
- Pregnancy
- Patients with liver metastases that cannot be completely and safely treated
- Active cancers other than CRC
- Non-resected primary colon cancer
- Advanced liver disease or evidence of liver insufficiency
Key Trial Info
Start Date :
September 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03775980
Start Date
September 4 2019
End Date
January 31 2026
Last Update
February 9 2024
Active Locations (1)
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1
CIRSE Cardiovascular and Interventional Radiological Society of Europe
Vienna, Austria, 1010