A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Auris Health, Inc.
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to 80 years of age;
- •Capable and willing to give informed consent;
- •Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- •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
- •Medical contraindication to bronchoscopy;
- •Ground glass opacity lesions on pre-procedure CT
- •Participation in any other clinical trial 30 days before and throughout the duration of the study;
- •Uncontrolled or irreversible coagulopathy;
- •Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test;
- •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.
Arms & Interventions
Robotic Bronchoscopy
Robotic bronchoscopy with Robotic Bronchoscopy Platform
Intervention: Robotic Bronchoscopy Platform (Device)
Outcomes
Primary Outcomes
Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform
Time Frame: During the procedure, up to 2 hours
Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.
Secondary Outcomes
No secondary outcomes reported