EPIONE Guided Lung Evaluation

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

Detailed Description
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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

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: EPIONE device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device | Device: EPIONE device<br>* The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the device | Number of targets reached ; the target is considered reached when the needle is positioned accurately enough to allow the planned procedure to be performed. | an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle placement accuracy | accuracy of the needle placement: deviation between the planned and actual needle position once inserted. | an average of 7 months | 
| Number and grade of needle adjustments | Detail of the number/nature of adjustments performed after the initial insertion of the needle. | an average of 7 months | 
| Post-intervention ablation success | Minimal Ablation Margin(s) measure(s) (mm) (if aplicable) | through study completion, an average of 1 year | 
| Long-term efficacy of ablation | Evaluation of the local tumor progression following the ablation (if applicable) | through study completion, an average of 1 year | 
| Adverse event | Safety of the device and the procedure | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous, CT-guided, Ablation, Biopsy, Abcess Drainage, Fiducial placement, Lung, Robotics