Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice (Match 2)

Noah Medical

Status: Active, not recruiting

Conditions: Lung Cancer; Lung; Nodule

Treatments: Device: Robotic assisted bronchoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT06685133

NOAH-003

Details and patient eligibility

About

A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Intervention/Treatment

Description:

Subjects who undergo bronchoscopy of the airways using the Galaxy System.

Treatment:

Device: Robotic assisted bronchoscopy