CIRSE Emprint Microwave Ablation Registry (CIEMAR)
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|ClinicalTrials.gov Identifier: NCT03775980|
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment|
|Colorectal Neoplasms Malignant Neoplasm Metastasis||Device: Emprint Microwave Ablation System|
The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System.
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 will observe the use of the Emprint Microwave Ablation System and all patients included in CIEMAR will receive treatment with this device as their standard care for CRLM.
Primary endpoint: local tumour control in liver at 12 months after the microwave ablation treatment on a per lesion basis
Secondary objectives: 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; Economic aspects
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 will incorporate 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 registry is currently in design and it is planned to start patient inclusion in January 2020. The target is to enrol 1000 patients and patient enrolment will stop two years after the enrolment of the first patient. A follow-up period of three years has been defined by the CIEMAR Steering Committee.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||CIRSE Emprint Microwave Ablation Registry|
|Actual Study Start Date :||September 4, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||July 30, 2025|
- Device: Emprint Microwave Ablation System
Microwave Ablation of colorectal liver metastases
- Local Tumor Control [ Time Frame: 12 months ]Local Tumor Control at 12 months on a per lesion basis
- Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE [ Time Frame: 3 years ]Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.
- Overall survival [ Time Frame: 3 years ]Time from observation until death due to any cause (or censoring)
- Overall disease-free-survival [ Time Frame: 3 years ]Time from observation until disease progression or death assessed by the investigators
- Hepatic disease-free-survival [ Time Frame: 3 years ]Time from observation until disease progression in the liver or death assessed by the investigators.
- Time to untreatable progression by thermal ablation [ Time Frame: 3 years ]Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.
- Systemic cancer therapy vacation [ Time Frame: 3 years ]Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.
- Treatment specific quality of life [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775980
|Contact: Robert Bauer, MA||+43 1 904 2003 email@example.com|
|Contact: Daniela Schweiger, PhD||+43 1 904 2003 firstname.lastname@example.org|
|Study Chair:||Phillippe L. Pereira, PhD||Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany|
|Study Chair:||Thierry de Baère, PhD||Departement of therapeutic radiology, Institut Gustave Roussy, Villejuif, France|