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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Nodes, Lung
• Interventions: Device: Robotic assisted bronchoscopy

• Registration Number: NCT06056128
• Lead Sponsor: Noah Medical

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.

Study Timeline

• Study Start: 2023-08-18
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Primary Completion: 2024-10-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic assisted bronchoscopy	Robotic assisted bronchoscopy	Robotic assisted bronchoscopy procedures performed using the Galaxy System.

Primary Outcome Measures

Name	Time	Method
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.	During the procedure	Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure	Up to 7 days post-procedure	Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield	Between 7 days and 6 months post-procedure	Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.
Center strike as confirmed by CBCT	During the procedure	Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.

Trial Locations

Locations (1)

Chinese University of Hong Kong, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong