NCT04182815

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 691 (actual)
• Sponsor: Auris Health, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Detailed description

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains 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. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal. A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Conditions

• Pulmonary Nodule
• Lung Cancer

Interventions

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

Timeline

• Start date: 2019-12-10
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2019-12-02
• Last updated: 2025-02-28

Locations

19 sites across 3 countries: United States, Canada, China

Regulatory

• FDA-regulated device study