Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integr… (NCT06056128) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
Hong Kong25 participantsStarted 2023-08-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18
✓. 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
✓. 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
✓. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
✓. PPNs that are accessible bronchoscopically on planning CT reconstruction
✓. Informed consent properly obtained per local regulations
Exclusion criteria
✕. Known pregnancy or breastfeeding
✕. Patients with pure ground-glass nodules on pre-procedural chest CT
✕. Uncontrolled coagulopathy or bleeding disorders
✕. Ongoing systemic infection
✕. History of lobectomy or pneumonectomy
✕. 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 per PI's discretion
What they're measuring
1
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Timeframe: During the procedure
2
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure