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

Lung Cancer Clinical Trial

— TiLT  

Official title:

Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology in Human Subjects to Bronchoscopically Biopsy Small Peripheral Pulmonary Nodules: TiLT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056128
• Other study ID #: NOAH-002
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: Noah Medical
• Contact: Ami Shah
• Phone: 9253390606
• Email: amishah[@]noahmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Nodes, Lung

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Noah Medical

Country where clinical trial is conducted

Hong Kong, 

Outcome

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