Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

Korábbi kezelés

• Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
• Have an implantable device, including pacemakers or other electronic implants.
• Subject had a prior pneumonectomy.
• Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Más betegség

• Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves).
• Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
• Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
• Diagnosis of Small Cell Lung Cancer.
• Any patient with clinically significant interstitial lung disease in the zone of planned ablation.

Laborértékek

• Have bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10\^9/L.
• Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.

Egyéb

• Patients who:
• Are pregnant or breast feeding, as determined by standard site practices.
• Have an expected survival less than 12 months.
• Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.

• Patients who:
• Have signed informed consent.
• Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
• Are ≥ 18 years old.
• Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer.
• Have soft tissue lung lesion(s):
  • ≤ 30 mm in the largest dimension of the pulmonary window for Stage A.
  • ≤ 20 mm in the largest dimension of the pulmonary window for Stage B.
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
• Subject is willing and able to comply with the study protocol requirements.
• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.