Epione® Post-Market Clinical Follow-up Study

Study Overview
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Brief Summary
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Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen

Detailed Description
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The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen. 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, operator satisfaction) and the safety of the device 55 patients are planned in this post-market study.

Official Title
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Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

Conditions
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Cancer Abdomen

Intervention / Treatment
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* Device: EPIONE® CT-Guided Percutaneous procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient >18 years old, Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians, Patient with a confirmed non-opposition. Exclusion Criteria: Patient unable to undergo general anesthesia, Pregnant or breast-feeding females

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention with the EPIONE® device<br>Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device | Device: EPIONE® CT-Guided Percutaneous procedures<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 |
| --- | --- | --- |
| Technical Success | Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed. | through study completion up to 36 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 | through study completion up to 36 months | 
| Number and nature of needle adjustments to reach the target | Detail of the number/nature of adjustments performed after the initial insertion of the needle | through study completion up to 36 months | 
| Post-intervention ablation success | Minimal Ablation Margin(s) measure(s) if applicable (mm) | through study completion up to 36 months | 
| Local tumor recurrence | Evaluation of the local tumor progression following the ablation (if applicable) | through study completion up to 36 months | 
| Operator satisfaction | 5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied | through study completion up to 36 months | 
| Adverse Events related to device or procedure | Safety of the device | through study completion up to 36 months | 
| Device dysfunction | Evaluation of the device dysfunction | through study completion up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous, CT-guided, Ablation, Biopsy, Abscess Drainage, Fiducial Placement, Abdomen, Liver, Kidney, Robotics