Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04072224 |
| Other study ID # |
Local/2018/02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2018 |
| Est. completion date |
October 23, 2020 |
Study information
| Verified date |
January 2023 |
| Source |
Centre Hospitalier Universitaire de Nimes |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Microwave thermal ablation (MO) is recognized as an alternative to surgery for the
local-regional treatment of primary and secondary hepatic and renal tumors and for secondary
pulmonary tumors in patients at anesthetic and/or surgical risk.
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.
Description:
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.
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.
