NCT03775980

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
12 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

September 4, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

December 11, 2018

Last Update Submit

February 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Local Tumor Control

    Local Tumor Control at 12 months on a per lesion basis

    12 months

Secondary Outcomes (7)

  • Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE

    3 years

  • Overall survival

    3 years

  • Overall disease-free-survival

    3 years

  • Hepatic disease-free-survival

    3 years

  • Time to untreatable progression by thermal ablation

    3 years

  • +2 more secondary outcomes

Interventions

Microwave Ablation of colorectal liver metastases

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease

You may qualify if:

  • 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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

University Hospital Centre Sisters of Mercy

Zagreb, 10000, Croatia

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

University Hospital of Nimes

Nîmes, 30900, France

Location

CHU de Reims

Reims, 51092, France

Location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

DRK Kliniken Berlin Westend

Berlin, 14050, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Krankenhaus Nordwest

Frankfurt, 60488, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60596, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

SLK Kliniken Heilbronn

Heilbronn, 74078, Germany

Location

Krankenhaus Barmherzige Brüder München

Munich, 80639, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Tübingen University Hospital

Tübingen, 72076, Germany

Location

Attikon University Athens

Athens, 12462, Greece

Location

Fondazione Poliambulanza Brescia

Brescia, 25124, Italy

Location

IRCCS San Giuseppe Multimedica

Milan, 20123, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Ospedaliero Universitaria San Luigi Gonzaga di Orbassano

Orbassano, 10043, Italy

Location

Ospedale Santissima Annunziata

Taranto, 74121, Italy

Location

Città della Salute e della scienza Torino

Torino, 10126, Italy

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08406, Lithuania

Location

Amsterdam University Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333, Netherlands

Location

City General Hospital 8th September

Skopje, 1000, North Macedonia

Location

Oslo University Hospital

Oslo, 0372, Norway

Location

Centro Hospitalar Universitário de Lisboa Central

Lisbon, 1169-050, Portugal

Location

IPO Porto

Porto, 4200-072, Portugal

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Cukurova University Medical School

Adana, 01790, Turkey (Türkiye)

Location

Hacettepe University Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Phillippe L. Pereira, PhD

    Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 14, 2018

Study Start

September 4, 2019

Primary Completion

January 3, 2023

Study Completion

January 31, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations