Lung Cancer
Conditions
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.
Interventions
DEVICERobotic Bronchoscopy Platform
Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Sponsors
Auris Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robotic Bronchoscopy Robotic bronchoscopy with Robotic Bronchoscopy Platform
Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Robotic Bronchoscopy | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 4 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 2 / 4 |
Outcome results
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.
Time frame: During the procedure, up to 2 hours
Population: due to termination after 4 subjects enrolled, no statistical analyses would have been performed or would be considered scientifically appropriate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Bronchoscopy | Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform | 4 Participants |