Ensayos clínicos

Inclusion Criteria:

• Signed informed consent.
• Patients ≥ 18 years old. 
• Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification. 
• Willing to fulfill all follow-up visit requirements. 
• Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease). 
• One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura.
  • Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura) 
• Radiographic resolution of pneumonia.

Exclusion Criteria: 

• Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related. 
• Pregnant or breastfeeding. 
• Physical or psychological condition that would impair study participation. 
• Patients with uncorrectable coagulography at time of screening. 
• Patient with implantable devices, including pacemakers or other electronic implants. 
• Prior pneumonectomy or bronchiectasis. 
• Severe neuromuscular disease. 
• Platelet count ≤ 50,000/mm3. 
• ASA (American Society of Anesthesiologists) score of ≥ 4. 
• Inability to tolerate anesthesia. 
• Expected survival less than 6 months. 
• Clinically significant hypertension. 
• Chronic ventilator support, which uses bi-level positive airway pressure (PAP). 
• Endobronchial soft tissue lesions proximal to the segmental airways.