Clinical trial · Observational
CIRSE Emprint Microwave Ablation Registry
NCT03775980CI-TRIAL-00111429CIEMARcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Emprint Microwave Ablation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Local Tumor Control
- timeFrame
- 12 months
- description
- Local Tumor Control at 12 months on a per lesion basis
Secondary outcomes (7)
- measure
- Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE
- timeFrame
- 3 years
- description
- Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.
- measure
- Overall survival
- timeFrame
- 3 years
- description
- Time from observation until death due to any cause (or censoring)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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, 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
References
Publications (1)
- BACKGROUNDPereira PL, Bale R, Fretland AA, Goldberg SN, Helmberger T, Meijerink MR, Orsi F, Stattner S, Vogl T, Kafkoula A, de Jong N, Zeka B, de Baere T. Local Tumour Control Following Microwave Ablation: Protocol for the Prospective Observational CIEMAR Study. Cardiovasc Intervent Radiol. 2024 Jan;47(1):121-129. doi: 10.1007/s00270-023-03573-0. Epub 2023 Oct 26. PMID 37884801