NCT06056128

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Noah Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Robotic assisted bronchoscopy	Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions

Timeline

• Start date: 2023-08-18
• Primary completion: 2024-10-22
• Completion: 2025-04-30
• First posted: 2023-09-28
• Last updated: 2025-04-25

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study