Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

Summary

The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.

Eligibility

Inclusion Criteria:

Patients who:

1. Have signed informed consent.
2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
3. Are ≥ 18 years old.
4. Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer.
5. 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.
6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
7. Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
8. Subject is willing and able to comply with the study protocol requirements.
9. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion Criteria:

Patients who:

1. 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).
2. Are pregnant or breast feeding, as determined by standard site practices.
3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
5. Have an expected survival less than 12 months.
6. Have bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10\^9/L.
7. Have an implantable device, including pacemakers or other electronic implants.
8. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).
9. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
10. Subject had a prior pneumonectomy.
11. Diagnosis of Small Cell Lung Cancer.
12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
13. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
14. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Conditions2

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