Status:
ACTIVE_NOT_RECRUITING
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
Lead Sponsor:
Noah Medical
Conditions:
Lung Cancer
Nodes, Lung
Eligibility:
All Genders
18+ years
Phase:
NA
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 maneu...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients with pacemakers or defibrillators
- Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06056128
Start Date
August 18 2023
End Date
April 30 2025
Last Update
April 25 2025
Active Locations (1)
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1
Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, Hong Kong