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

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

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Robotic Bronchoscopy Platform

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Mountain View, California, United States, 94040
      • Palo Alto Medical Foundation Mountain View Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Bronchoscopy; Robotic bronchoscopy with Robotic Bronchoscopy Platform	Device: Robotic Bronchoscopy Platform; Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.; Other Names: The Monarch Platform

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Auris Health, Inc.
• Investigators: Principal Investigator: Ganesh Krishna, MD, El Camino Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): July 10, 2018

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DD082015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No