Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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,…
What they're measuring
1
Local Tumor Control
Timeframe: 12 months
Trial details
NCT IDNCT03775980
SponsorCardiovascular and Interventional Radiological Society of Europe