None listed
Conditions
Brief summary
The aim of the Noah Medical FRONTIER Study is to assess the safety, efficacy and feasibility of the Galaxy Robotic Bronchoscopy System for the sampling of small peripheral pulmonary (lung) nodules that are suspected of being cancerous. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have a moderate to high risk of lung cancer based on clinical, demographic, and imaging information, you have had a lung CT scan within 30 days of the pending bronchoscopy procedure and your specialist has indicated that your nodules are of an appropriate size and shape for biopsy via bronchoscopy. Study details All participants who choose to enrol in this study will undergo pre-operative and post-operative procedures in line with the standard method of lung nodule biopsy. Prior to your procedure this involves having a physical examination, medical history and CT scan of the Chest performed. Following your procedure you will be monitored for any side effects of the biopsy process and also have a Chest X-Ray to assess your lungs and the area that has been biopsied. Participants in this study will then have one of their nodules biospied using the Noah Medical Galaxy Robotic Bronchoscopy System. The Galaxy system reads the pre-operative CT scan and uses this information to locate a suspicious nodule for biopsy. If the robotic system is unable to locate and reach the pulmonary nodule, standard of care methods using probes inserted via a conventional bronchoscope will be used to sample the pulmonary nodule. Participants who chose to enrol will be followed at 24-28 hours post-operation and then 7 days following their procedure. If a diagnosis is unable to be made at this time participants will be required to be followed up at 6 months to check on the progress of their pulmonary nodule. It is hoped this research will determine whether use of a novel robotic biopsy system is safe and feasible for use in patients with a moderate to high risk of lung cancer. If the robotic system is found to be safe and effective for biopsy of suspected cancer nodules, it may be used more widely for the treatment of future lung cancer patients
Interventions
Use of the Noah Medical Galaxy Robotic Bronchoscopy System for the biopsy of small peripheral pulmonary nodules, will be performed in a bronchoscopy suite by a specialist respiratory physician (interventional pulmonologist).
Prior to the interventional pulmonologist performing the procedure in the clinical trial they will have been trained by a suitably qualified representative from the sponsor (Noah Medical) in a didactic and practical training lab (performed at Macquarie University Clinical
Use of the Noah Medical Galaxy Robotic Bronchoscopy System for the biopsy of small peripheral pulmonary nodules, will be performed in a bronchoscopy suite by a specialist respiratory physician (interventional pulmonologist). Prior to the interventional pulmonologist performing the procedure in the clinical trial they will have been trained by a suitably qualified representative from the sponsor (Noah Medical) in a didactic and practical training lab (performed at Macquarie University Clinical Training Unit). The subject will be anaesthetised by a qualified anaesthetist using mechanisms that are suitable for that particular subject. Subjects may have more than one nodule sampled but will only have one procedure under the Galaxy System protocol. if further nodules are to be sampled at a later stage these will be sampled using standard of care techniques. It is anticipated that the procedure will take approximately one hour. The preparation and post operative follow up will be according to standard of care for a subject undergoing bronchoscopic biopsy of a small peripheral pulmonary nodule. This includes physical exam, medical history, CT of Chest (lung) and respiratory function tests to assess lung function. These assessments are standard for subjects undergoing bronchoscopic biopsy of lung nodules. The Noah Medical Galaxy Biopsy system uses a CT Scan of the Chest obtained from the subject to identify the area of lung in which the nodule exists. The data from this CT is used by the Galaxy system to navigate to the lung region in order to biopsy the nodule. In the unlikely occurrence that the Galaxy System cannot access the lung nodule for biopsy, an attempt will be made using standard of care approaches including the use of radial EBUS (endobronchial ultrasound) and fluoroscopy.
Sponsors
Noah Medical Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed