Clinical trial NCT03497026: Auris Robotic Endoscopy System for Bronchoscopy
Official title: A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Auris Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform
timeFrame: During the procedure, up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Mountain View
country: United States
facility: Palo Alto Medical Foundation Mountain View Center
state: California
Study officials:
affiliation: El Camino Hospital
name: Ganesh Krishna, MD
role: PRINCIPAL_INVESTIGATOR
References: