Colorectal Neoplasms MalignantCIEMARNCT03775980
CIRSE Emprint Microwave Ablation Registry
An observational study of Colorectal Neoplasms Malignant and Neoplasm Metastasis, run by Cardiovascular and Interventional Radiological Society of Europe at 38 sites in 13 countries.
Trial summary
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Neoplasms Malignant, Neoplasm Metastasis
- What is being tested?
- Emprint Microwave Ablation System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 38 sitesin 13 countries
- Study dates
- 4 Sep 2019to 31 Jan 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
38 sites in 13 countries.
38 sites in 13 countries
Germany12 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Vivantes Klinikum Neukölln
Berlin, 12351
DRK Kliniken Berlin Westend
Berlin, 14050
Städtisches Klinikum Braunschweig
Braunschweig, 38126
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Krankenhaus Nordwest
Frankfurt, 60488
Universitätsklinikum Frankfurt
Frankfurt, 60596
Medizinische Hochschule Hannover
Hanover, 30625
SLK Kliniken Heilbronn
Heilbronn, 74078
Krankenhaus Barmherzige Brüder München
Munich, 80639
Universitätsklinikum Regensburg
Regensburg, 93053
Tübingen University Hospital
Tübingen, 72076
Italy7 sites
Fondazione Poliambulanza Brescia
Brescia, 25124
IRCCS San Giuseppe Multimedica
Milan, 20123
IRCCS Ospedale San Raffaele
Milan, 20132
European Institute of Oncology
Milan, 20141
Ospedaliero Universitaria San Luigi Gonzaga di Orbassano
Orbassano, 10043
Ospedale Santissima Annunziata
Taranto, 74121
Città della Salute e della scienza Torino
Torino, 10126
France3 sites
University Hospital of Nimes
Nîmes, 30900
CHU de Reims
Reims, 51092
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Netherlands3 sites
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, 9713
Leids Universitair Medisch Centrum
Leiden, 2333
Spain3 sites
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Portugal2 sites
Centro Hospitalar Universitário de Lisboa Central
Lisbon, 1169-050
IPO Porto
Porto, 4200-072
Turkey (Türkiye)2 sites
Cukurova University Medical School
Adana, 01790
Hacettepe University Hospital
Ankara, 06230
Lithuania1 site
Vilnius University Hospital Santaros Klinikos
Vilnius, 08406
North Macedonia1 site
City General Hospital 8th September
Skopje, 1000
About this study
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
Read the 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).
- Being tested
- Emprint Microwave Ablation System
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emprint Microwave Ablation SystemDevice
Microwave Ablation of colorectal liver metastases
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control
Local Tumor Control at 12 months on a per lesion basis
Measured: 12 months
Secondary outcomes (7)
Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE
Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.
Measured: 3 years
Overall survival
Time from observation until death due to any cause (or censoring)
Measured: 3 years
Overall disease-free-survival
Time from observation until disease progression or death assessed by the investigators
Measured: 3 years
Hepatic disease-free-survival
Time from observation until disease progression in the liver or death assessed by the investigators.
Measured: 3 years
Time to untreatable progression by thermal ablation
Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.
Measured: 3 years
Systemic cancer therapy vacation
Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.
Measured: 3 years
Treatment specific quality of life
Treatment specific quality of life will be assessed using the EORTC-QLQ-C30 questionnaire which includes 28 questions on a scale of 1 to 4 where 1 indicates lower impact of the disease on the patient's quality of life and 4 represents a high impact. Additionally 2 questions using a scale form 1 to 7 are used to generally assess the patient's quality of life where 1 represents poor quality of life and 7 represents an excellent quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start4 Sep 2019
- Primary completion3 Jan 2023
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Phillippe L. Pereira, PhD, Study chair, Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775980
- Sponsor's protocol ID
- CIEMAR
- Acronym
- CIEMAR
- Status last verified
- May 2026
- First submitted
- 11 Dec 2018
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira 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.
PubMed 37884801Meijerink M, Schulz H, Fretland AA, Bale R, Arnold D, Balli T, Gazzera C, Staettner S, Helmberger T, Vogl T, Kafloula A, Zeka B, Urdaniz M, Orsi F, Pereira PL. Results from the Pan-European CIEMAR study: Local Tumour Control After Microwave Ablation of Colorectal Liver Metastases and Exploratory Associations with Ablation Margins and Confirmation Software. Cardiovasc Intervent Radiol. 2026 Sep 6. doi: 10.1007/s00270-026-04578-1. Online ahead of print.
PubMed 42701958
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRSE Emprint Microwave Ablation Registry
- ClinicalTrials.gov ID
- NCT03775980
- Acronym / sponsor ID
- CIEMAR / CIEMAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of EuropeUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emprint Microwave Ablation SystemMicrowave Ablation of colorectal liver metastases | Device | – |
Primary outcome
Local Tumor Control
Time frame: 12 months
Local Tumor Control at 12 months on a per lesion basis
7 secondary outcomes
Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE
Time frame: 3 years
Overall survival
Time frame: 3 years
Overall disease-free-survival
Time frame: 3 years
Hepatic disease-free-survival
Time frame: 3 years
Time to untreatable progression by thermal ablation
Time frame: 3 years
Systemic cancer therapy vacation
Time frame: 3 years
Treatment specific quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 37884801Pereira 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.
- Derived from this study: PubMed 42701958Meijerink M, Schulz H, Fretland AA, Bale R, Arnold D, Balli T, Gazzera C, Staettner S, Helmberger T, Vogl T, Kafloula A, Zeka B, Urdaniz M, Orsi F, Pereira PL. Results from the Pan-European CIEMAR study: Local Tumour Control After Microwave Ablation of Colorectal Liver Metastases and Exploratory Associations with Ablation Margins and Confirmation Software. Cardiovasc Intervent Radiol. 2026 Sep 6. doi: 10.1007/s00270-026-04578-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillippe L. Pereira, PhD study chair
Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany
38 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms Malignant and Neoplasm Metastasis, run by Cardiovascular and Interventional Radiological Society of Europe at 38 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Italy, France, Netherlands, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.