Auris Robotic Endoscopy System for Bronchoscopy

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03497026
• Other study ID #: DD082015
• Status: Terminated
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: July 10, 2018

Study information

• Verified date: September 2021
• Source: Auris Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Robotic Bronchoscopy Platform
Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California
United States	Palo Alto Medical Foundation Mountain View Center	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Auris Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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