oah Medical FRONTIER Study: First Human Use of a New Robotic Electromagnetic Navigation Bronchoscopy with Integrated Tool-In-Lesion-Tomosynthesis (TiLT) Technology (Galaxy System) for Small Peripheral Pulmonary Nodules
- Conditions
- Peripheral Pulmonary NodulesRespiratory - Other respiratory disorders / diseasesCancer - Lung - Non small cell
- Registration Number
- ACTRN12622001440718
- Lead Sponsor
- oah Medical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
Age greater than or equal to 18 years of age
Patients with a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information, determined by the Interventional Pulmonary Nodule MDT based on the site’s standard of care
Solid peripheral pulmonary nodules (PPNs) sized 1 to 3 cm measured as the largest dimension
Pre-procedural CT is conducted within 30 days of the bronchoscopy procedure
Peripheral Pulmonary Nodules that are accessible bronchoscopically on planning CT reconstruction based on MDT discussion
Informed consent properly obtained per local regulations
Known pregnancy or breastfeeding
Patients with a subsolid nodule (pure or partly solid ground-glass nodules) on pre-procedural chest CT
Uncontrolled coagulopathy or bleeding disorders
Ongoing systemic infection
Past history of lobectomy
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
Patients with implanted pacemakers or defibrillators
Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Patients who are unable to provide written informed consent to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method