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

NCT06056128 | Active Not Recruiting FDA Device

• 1 other identifier: NOAH-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Nodes, Lung

Keywords

Lung cancer, robotic assisted bronchoscopy

Outcome Measures

Primary Outcomes (2)

• Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.

  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.

  During the procedure

• Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure

  Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

  Up to 7 days post-procedure

Secondary Outcomes (2)

• Diagnostic yield

  Between 7 days and 6 months post-procedure

• Center strike as confirmed by CBCT

  During the procedure

Study Arms (1)

Robotic assisted bronchoscopy

EXPERIMENTAL

Robotic assisted bronchoscopy procedures performed using the Galaxy System.

Device: Robotic assisted bronchoscopy

Interventions

Robotic assisted bronchoscopy DEVICE

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

Robotic assisted bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noah Medical: lead

Study Sites (1)

Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Calvin Ng, MD

  Chinese University of Hong Kong, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: August 18, 2023
• Primary Completion: October 22, 2024
• Study Completion: April 30, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)