| Eligibility |
Inclusion Criteria:
1. Signed the informed consent form and willing to fulfill the study-related assessments
and procedure schedule.
2. Lung tumor patients = 18 years of age who are ineligible for/decline surgery and who
plan to receive microwave ablation therapy.
3. ECOG performance status score of 0-2.
4. Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients
with clinically diagnosed oligometastatic lung tumor.
5. Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or a
maximum of three ipsilateral oligometastatic lung tumors.
6. Tumor(s) to be ablated in a single surgery should be = 2cm, locate in the outer
two-thirds of a lung, not closer than 1 cm from the hilum of lung, great vessels,
principal bronchus, trachea or esophagus, and not contiguous with the pleura.
Exclusion Criteria:
1. Pregnant or breast-feeding.
2. Patients with implantable pacemakers or other electronic implants.
3. Oligometastatic tumors patients whose primary lesion cannot be controlled or have
widely metastases, in the opinion of the investigator and/or treating oncologist.
4. Any planned concurrent procedure at the time of ablation.
5. Planned treatment for other tumors in the same side lung during the study period.
6. With a skin infection or ulceration at the site to be punctured by probe(s).
7. Clinical or imaging findings consistent with an active pulmonary infection.
8. Patients with severe pulmonary fibrosis in the area intended to ablate, especially
drug-induced pulmonary fibrosis.
9. Patients with prior radiotherapy in the area intended to ablate.
10. Patients with uncontrolled malignant pleural effusion at the lung side with tumor to
ablate.
11. Tumors where the anticipated zone of ablation would encompass significant (in the
opinion of the treating physician) emphysematous or bullous disease.
12. The investigator anticipates that the ablation zone of the multiple tumor(s) to be
ablated may have overlapping ablation zones.
13. Patients who have received lung ablation or surgical resection therapy within 30 days
prior to the ablation procedure under study and those who plan to receive lung tumor
ablation or surgical resection therapy or radiation therapy on the ablated lung side
before completing the primary efficacy endpoint assessment approximately 30 days after
the ablation procedure.
14. Patients who received systemic therapy such as chemotherapy, targeted drug therapy, or
immunotherapy within 7 days prior to the ablation procedure under study, and patients
who had a systemic treatment plan such as chemotherapy, targeted drug therapy,
immunotherapy, etc. before completing the primary efficacy endpoint assessment
approximately 30 days after the ablation procedure.
15. Patients with uncorrectable coagulopathy based on investigator judgment.
16. Patients with a platelet count = 50 × 109/L.
17. Patients who cannot discontinue antiplatelet medication (e.g., aspirin, clopidogrel,
prasugrel, ticagrelor) at least 5 days before the ablation procedure through 24 hours
post-procedure.
18. Patients who cannot discontinue anticoagulant medication (e.g., rivaroxaban, apixaban,
dabigatran, edoxaban) at least 3 days before the ablation procedure through 24 hours
post-procedure.
19. Patients who cannot discontinue warfarin before at least 5 days before the ablation
procedure of the study or have an INR > 1.5.
20. As judged by the investigator, the patient has hypertension that cannot be effectively
controlled by pharmacological treatments.
21. Severe hepatic, renal, cardiac, pulmonary or cerebral insufficiency, severe anemia,
dehydration, and severe nutrition and metabolism disorders, which cannot be corrected
or improved within a short term; or serious systemic infection; or severe
neuromuscular diseases.
22. Expected survival less than 6 months.
23. Participation in any other interventional clinical study within 30 days before
screening.
24. Physical or psychological condition which would impair study participation.
25. Patient is judged unsuitable for study participation by the investigator for any other
reason.
Intra-Ablation Exclusion Criteria:
26. Before ablation probe puncture on the skin, patient is judged unsuitable for study
participation due to intolerance to anesthesia.
27. Before ablation probe puncture on the skin, patient is judged unsuitable for study
participation due to presenting any other condition.
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