EPIONE Guided Lung Evaluation

Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

The objectives are:

• to evaluate the technical success of the device

• to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence)

• to evaluate the safety of the device

  25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device

Inclusion Criteria:

• Patient ≥18 years old,
• Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
• Patient with a signed informed consent form.
• Patient covered by a social security system.

Exclusion Criteria:

• Patient unable to undergo general anesthesia,
• Pregnant or nursing female, confirmed before the intervention
• Patient already participating in another clinical study