Auris Robotic Endoscopy System for Bronchoscopy

Not Applicable

Terminated

• Conditions: Lung Cancer
• Interventions: Device: Robotic Bronchoscopy Platform

• Registration Number: NCT03497026
• Lead Sponsor: Auris Health, Inc.

Brief 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.

Study Timeline

• Study Start: 2018-03-30
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-13
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-10
• Status Verified: 2021-09
• Results First Submitted: 2021-09-22
• Results First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Results First Posted: 2021-11-15
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
4. Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy

Exclusion Criteria

1. Medical contraindication to bronchoscopy;
2. Ground glass opacity lesions on pre-procedure CT
3. Participation in any other clinical trial 30 days before and throughout the duration of the study;
4. Uncontrolled or irreversible coagulopathy;
5. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test;
6. CT scan done over a month before the bronchoscopy procedure.

Intra-Procedure Exclusion Criteria: Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient's best interest.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Bronchoscopy	Robotic Bronchoscopy Platform	Robotic bronchoscopy with Robotic Bronchoscopy Platform

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform	During the procedure, up to 2 hours	Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.

Trial Locations

Locations (2)

Palo Alto Medical Foundation Mountain View Center; 🇺🇸 Mountain View, California, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States