Robotic assisted bronchoscopy: Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.
Study summary
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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