NEUWAVE Flexible Probe Study #2

Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the
lung less than 2cm will undergo transbronchial microwave ablation performed by an
interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe
guidance and confirmation on ablation outcome. All treated patients will be followed for one
year following the ablation procedure for efficacy and safety.

Inclusion Criteria:

1. Signed Informed Consent

2. Patients greater or equal to 18 years of age

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

4. Willing to fulfill all follow-up visit requirements

5. Medically inoperable and operable secondary soft tissue lesion(s) of the lung

6. A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the
outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must
be measured with at least 2-dimensional imaging.

Exclusion Criteria:

1. Scheduled concurrent procedure for the target soft tissue lesion(s) 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 coagulopathy at the time of screening

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

6. Prior pneumonectomy or bronchiectasis

7. Severe neuromuscular disease

8. Patient count less than or equal to 50,000/mm cubed

9. ASA (American Society of Anesthesiologists) score of greater than or equal to 4

10. Inability to tolerate anesthesia

11. Expected survival less than 6 months

12. Clinically significant hypertension

13. Chronic, continuous ventilator support, which uses bi-level positive airway pressure
(PAP) to improve lung function for severe conditions (however, intermittent PAP, for
non-pulmonary conditions, such as sleep apnea, is permitted)

14. Endobronchial soft tissue lesions proximal to the segmental airways

15. Imaging findings of active pulmonary infection

16. The patient was judged unsuitable for study participation by the Investigator for any
other reason.