NCT03727425

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Auris Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Detailed description

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. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Conditions

• Lung; Node

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: 2018-11-01
• Primary completion: 2019-09-12
• Completion: 2020-06-30
• First posted: 2018-11-01
• Last updated: 2020-12-14
• Results posted: 2020-12-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study