Evaluation of the Reproducibility of Ablation Volumes at One Month After Microwave Treatment Compared to the Manufacturer's Abacus: on the Kidney, Liver and Lung
NCT ID: NCT04072224
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2018-10-23
2020-10-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Microwaves have a reputation for not producing reproducible ablation volumes with elliptical deformations and risks of over or under processing.
The Covidien manufacturer offers a microwave system that guarantees more spherical and reproducible ablations: Emprint TM ablation system with Thermosphere TM technology (thermal control, field control, wavelength control).
The investigators have 2 years of experience and therefore propose to carry out a first retrospective study, on a cohort of about fifty patients, whose objective will be to compare the volume of in vivo ablation one month after thermo-ablative treatment by microwave of a hepatic, renal or pulmonary tumour with the reference volume announced by the Covidien abacus manufacturer.
Microwave ablation, which is much less studied, is less used because of the low reproducibility of necrosis volumes.
The Covidien manufacturer offers a system that allows ablation volumes that are supposed to be reproducible, which attracted the Nîmes University Hospital during the call for tenders.
To the investigator's knowledge, there are no studies that have evaluated the actual volume of ablation by this system.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
NCT01862718
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
NCT02862288
Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy
NCT01986829
Standardization of Multi-modal Tumor Ablation Therapy System
NCT03223142
Microwave Ablation in Pulmonary Malignancies
NCT04081181
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Microwave ablation, which is much less studied, is less used because of the low reproducibility of necrosis volumes.
The Covidien manufacturer offers a system that allows ablation volumes that are supposed to be reproducible, which attracted the Nîmes University Hospital during the call for tenders.
To the investigator's knowledge, there are no studies that have evaluated the actual volume of ablation by this system.
This is a retrospective monocentric study that divides patients into three groups according to the organ concerned (liver, kidney, lung). It concerns patients with hepatic, renal or pulmonary tumours whose indication for treatment by thermo-ablation has been validated in RCP at the University Hospital of Nîmes.
Each patient was informed of the therapeutic management and was seen in interventional radiology consultation before the expected date of thermo-ablation.
A letter of no objection was sent to each patient prior to treatment. A CT or MRI control imaging is performed one month before the operation, systematically at the University Hospital of Nîmes after a thermo-ablative procedure.
The size of the ablation volume obtained is measured (major axis and minor axis) on this control imaging. This volume will be compared to the ablation volume planned by the manufacturer, depending on the power and duration of the impact chosen according to the size of the tumor (evaluated on the imaging prior to the procedure).
Data stored in Redcap. 50-60 patients included.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* primary hepatic or renal or secondary hepatic, renal or pulmonary tumor at the University Hospital of Nîmes between June 2016 and June 2018
* diagnosis and size of the tumour established on the basis of tomodensitometric (CT) or magnetic resonance (MRI) imaging.
Exclusion Criteria
* patients with progressive infectious process contraindicating the procedure and/or for whom thermo-ablation equipment other than Covidien has been used
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Nîmes
Nîmes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Local/2018/02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.