Snipe Medical First In Human Study
A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection
• Adult male and female subjects (age ≥18 years at the date of informed consent signature)
• Subject is capable and willing to provide an informed consent
• Subjects with a known diagnosis of lung cancer at cT1a-T1c, cN0 stages
• At least one pulmonary tumor (primary or metastasis) ≤ 30 mm in maximal diameter, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening
• Subjects who are scheduled or deemed eligible by a thoracic surgeon for lung tumor resection
• Subject is able and willing to comply with the study procedures and visits
• There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening
• ECOG 0-1
• Stable doses of concomitant medications for at least four (4) weeks prior to enrollment