NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than
or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to
the pleura) will have transbronchial microwave ablation performed using CT imaging. All
ablations will be performed under general anesthesia via transbronchial approach by an
interventional pulmonologist or thoracic surgeon.

Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to
confirm staging.

Patients will be followed for one year following the ablation procedure for efficacy and
safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A
user experience questionnaire is completed by the treating physician to better understand the
ease of the procedure.

Inclusion Criteria:

1. Signed informed consent.

2. Patients ≥ 18 years old.

3. Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.

4. Willing to fulfill all follow-up visit requirements.

5. 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)

6. 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)

7. Radiographic resolution of pneumonia

Exclusion Criteria:

1. Scheduled concurrent procedure for the target soft tissue lesion other than those that
are lung related.

2. Pregnant or breastfeeding.

3. Physical or psychological condition that would impair study participation.

4. Patients with uncorrectable coagulography at time of screening.

5. Patient with implantable devices, including pacemakers or other electronic implants.

6. Prior pneumonectomy or bronchiectasis.

7. Severe neuromuscular disease.

8. Platelet count ≤ 50,000/mm3.

9. ASA (American Society of Anesthesiologists) score of ≥ 4.

10. Inability to tolerate anesthesia.

11. Expected survival less than 6 months.

12. Clinically significant hypertension.

13. Chronic ventilator support, which uses bi-level positive airway pressure (PAP).

14. Endobronchial soft tissue lesions proximal to the segmental airways