Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology

Noah Medical

Status: Active, not recruiting

Conditions: Lung Cancer; Nodes, Lung

Treatments: Device: Robotic assisted bronchoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06056128

NOAH-002

Details and patient eligibility

About

This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Robotic assisted bronchoscopy

Experimental group

Description:

Robotic assisted bronchoscopy procedures performed using the Galaxy System.

Treatment:

Device: Robotic assisted bronchoscopy