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

NCT ID: NCT06056128

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-04-30

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 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.

Conditions

Lung Cancer; Nodes, Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Robotic assisted bronchoscopy

Robotic assisted bronchoscopy procedures performed using the Galaxy System.

Group Type: EXPERIMENTAL

Robotic assisted bronchoscopy

Intervention Type: DEVICE

Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions

Interventions

Robotic assisted bronchoscopy

Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noah Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calvin Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong, Prince of Wales Hospital

Locations

Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

NOAH-002

Identifier Type: -

Identifier Source: org_study_id