Lung Cancer, Lung; Nodule
Conditions
Brief summary
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
Detailed description
The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.
Interventions
Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.
Sponsors
Noah Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Patients with indeterminate lung nodule 3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT 4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure 5. 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. Patients with pacemakers or defibrillators 7. Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist 8. Patients with pleural effusion or diaphragmatic paralysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Navigation to the lesion | During the procedure | Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy. |
| Successful tool-in-lesion | During the procedure | Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT. |
| Serious Adverse Events | During the procedure and up to 7 days post procedure | Serious device or procedure related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | End of procedure and up to 2-years post-procedure | Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue. |
| Center Strike | During the procedure | Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT. |
Countries
United States
Outcome results
None listed