Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology (TiLT)
Lung Cancer, Nodes, Lung
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung cancer, robotic assisted bronchoscopy
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure PPNs that are accessible bronchoscopically on planning CT reconstruction Informed consent properly obtained per local regulations Exclusion Criteria: Known pregnancy or breastfeeding Patients with pure ground-glass nodules on pre-procedural chest CT Uncontrolled coagulopathy or bleeding disorders Ongoing systemic infection History of lobectomy or pneumonectomy Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion Patients with pacemakers or defibrillators Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Sites / Locations
- Chinese University of Hong Kong, Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Robotic assisted bronchoscopy
Robotic assisted bronchoscopy procedures performed using the Galaxy System.