First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

Korábbi kezelés

• Subjects with contraindication for tumor resection
• Active and/or prolonged lung or bronchi infection, required an antibiotic treatment up to 21 days prior to screening and for more than 10 days of treatment
• Previous surgery in the lung intended for ablation; thoracic major surgery at the side intended for ablation
• Subjects with implanted metal or electronic thoracic devices objects (such as pacemaker) that cannot be removed prior to procedure
• Participation in any other interventional clinical trial with medication, medical device and/or supplements within 30 days prior to informed consent signature

Más betegség

• Severe emphysema, Bullous Emphysema or chronic obstructive pulmonary disease (COPD) (GOLD III/IV)

Laborértékek

• Anticoagulation treatment that cannot be discontinued prior to the ablation, or a bleeding diathesis or platelets <100 )K/µl)

Életkor

• Total Lung Capacity (TLC)< 80% of expected for age

Egyéb

• An inability to provide informed consent
• Subjects with life expectancy <12 months
• Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
• Subjects with Forced Expiratory Volume (FEV1) <50%
• Diffusing Capacity (DCO) < 60% of expected
• Oxygen saturation in free air of <88%, or requiring more than 2 l/min oxygen to achieve saturation of 92%
• PCO2 of ≥ 45mm/Hg
• Subjects in exacerbations group E (high risk; ≥2 exacerbations per year or ≥1 requiring hospitalization and any level of symptoms)
• Known history or current evidence of a significant bronchiectasis
• Evidence of lung Bullae the occupies more than one third of the lung intended for ablation
• Pregnant or breastfeeding female subjects or female subjects who plan pregnancy during participation in the study
• Highly hypoxemic patients, according to investigator's discretion
• Subjects with contraindication for bronchoscopy
• Any subject who, at the discretion of the investigator, may be jeopardized by study participation

• 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