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

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:

1. to evaluate the technical success of the device
2. 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.

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

Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.

55 patients were included but 54 were analysed (1 patient was registered under 2 inclusion n°: n°3 and n°55. Patient n°55 was included due to tumor recurrence but was subsequently withdrawn from the study after consultation with the principal investigator, as the protocol does not account for the evaluation of secondary efficacy outcomes).

Among the 54 patients analysed: 30 males (55.6%) and 24 females (44.4%) representing 61 lesions which required 108 needle insertions during 56 procedures.

The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients).

Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.