Lung Cancer, Nodes, Lung
Conditions
Keywords
Lung cancer, robotic assisted bronchoscopy
Brief summary
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Detailed description
Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.
Interventions
Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions
Sponsors
Noah Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. 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 3. 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 4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure 5. PPNs that are accessible bronchoscopically on planning CT reconstruction 6. Informed consent properly obtained per local regulations
Exclusion criteria
1. Known pregnancy or breastfeeding 2. Patients with pure ground-glass nodules on pre-procedural chest CT 3. Uncontrolled coagulopathy or bleeding disorders 4. Ongoing systemic infection 5. History of lobectomy or pneumonectomy 6. Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. 7. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion 8. Patients with pacemakers or defibrillators 9. Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT. | During the procedure | Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed. |
| Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure | Up to 7 days post-procedure | Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Between 7 days and 6 months post-procedure | Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue. |
| Center strike as confirmed by CBCT | During the procedure | Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy. |
Countries
Hong Kong
Outcome results
None listed