Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection

Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection

In order to secure the diagnosis of lung cancer, the investigator will perform a bronchoscopy in order to take tissue samples. These samples will be analyzed in the pathology. This is the routine standard. The aim of the study is to treat the lesion with a device that works both with cold and radiofrequency. The device is already in use for the treatment of lesions. The device allows direct treatment of the lesion during the routine bronchoscopy. As planned, the lesion will then be surgically removed. After the surgery the lesion will be analyzed in the pathology to show the effect of the use of the device. This additional treatment is safe and will support the treatment of the lesion. There are no additional steps or assessments for the participants to undergo.

Inclusion Criteria:

• Solitary nodule ≤ 2.5 cm
• Candidate for diagnostic bronchoscopy & LN staging
• Eligible for surgical resection
• Histologically proven lung cancer
• ≥20 mm margin to pleura/vessels/bronchi
• Signed informed consent, age ≥18 y.

Exclusion Criteria:

• Pregnancy/nursing
• central tumours abutting vital structures
• thoracic electronic implants
• uncorrectable coagulopathy or platelets ≤50 × 10⁹/L
• severe uncontrolled comorbidities or infection; prior SBRT to zone
• recent investigational therapy (<30 d)
• atelectasis/obstructive pneumonitis/effusion/fibrosis
• investigator-determined risk.