NCT03497026

Auris Robotic Endoscopy System for Bronchoscopy

A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Auris Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.

Detailed description

The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy. However, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success. In this study , the novel Robotic Endoscopy Platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. Commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Robotic Bronchoscopy Platform	Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.

Timeline

• Start date: 2018-03-30
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2018-04-13
• Last updated: 2021-11-15
• Results posted: 2021-11-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study