Abstract No. 200 Interim Analysis of the Prospective Evaluation of Performance and Safety of the Epione-Assisted CT-Guided Percutaneous Treatments in the Lung (clinicaltrials.gov, NCT05651867)

Robotic-guidance in interventional radiology is rapidly developing. The Epione device (Quantum Surgical, Montpellier, France), CE marked and FDA cleared for abdomen, is CE marked and under evaluation by FDA for lung. Adult patients with indication of percutaneous CT-guided thermal intervention of lung tumor, validated in multidisciplinary tumor board, were included in this prospective study. The primary endpoint was the technical success of the treatment. Secondary endpoints were safety (device or intervention-related adverse events (AE) and deficiencies/dysfunctions) and performance (needle placement accuracy defined by distance between needle inserted and predefined planning), manual needle adjustments, post-intervention ablation success and local tumor control. Between November 2022 and August 2023, 25 patients, 18 (72%) men and 7 (28%) women, mean age 64.3 years old (±9.4) were included. They presented with 1 (n=23, 92%) or 2 lung tumors (n=2, 8%), among which 23/27 (85.2%) were metastatic. Patients were treated with radiofrequency (n=21, 84%) or cryoablation (n=5, 20%) by 3 different physicians. Eight patients (32%) also underwent a biopsy. The mean lesion size was 1.2 cm (±0.6). Over all treatments, 31 needles were inserted with robotic assistance, 1 needle for 19 patients (76%) and 2 needle for 6 patients (24%). Feasibility was reported in 26/27 tumors (96.3%), in 30/31 needles inserted (96.8%). Accuracy was 1.6 mm (±1.8) after 6/31 (19%) needle depth adjustments and 16/31 lateral adjustments; 2needle had to be retrieved and manually inserted in a single patient. Seven pneumothoraxes (28%) and two intra-alveolar minor hemorrhages were reported. Robotic assistance with the Epione device is highly feasible in lung treatments, with high safety and accurate needle placement after adjustments. This interim analysis allowed expanding indications beyond abdominal indications to lung tumors (CE mark) and will be submitted to FDA for extension to lung.