Lung Cancer, Pulmonary Nodule
Conditions
Keywords
Bronchoscopy, Robotic bronchoscopy, Lung Lesions, Peripheral lesions, Lung Cancer, Monarch
Brief summary
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.
Detailed description
Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal. A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.
Interventions
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Sponsors
Auris Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 21 years of age; 2. Capable and willing to give informed consent; 3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure; 4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy
Exclusion criteria
1. Medical contraindication to bronchoscopy as assessed by the investigator 2. Presence of uncorrectable bleeding disorders 3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker 4. Patients with the target lesion having endobronchial involvement seen on chest CT 5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, 6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study; 7. Uncontrolled or irreversible coagulopathy; 8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure; 9. CT scan done greater than 28 days before the bronchoscopy procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device or procedure related complications | up to 7 days post procedure | The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all pneumothoraxes | up to 7 days post procedure | — |
| Total procedure time | During the procedure | — |
| Rate of conversion to conventional bronchoscopic procedure | During the procedure | — |
| Rate of device or procedure related complications | up to 7 days post procedure | Individual components of the primary endpoint |
| Rate of adverse events unrelated to device or procedure | up to 7 days post procedure | — |
| Diagnostic yield | up to 24 months post procedure | Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples |
| Sensitivity for malignancy | up to 24 months post procedure | — |
| Rate of post-bronchoscopy infections | up to 7 days post-procedure | — |
| Stage at diagnosis | up to 24 months post procedure | Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer |
Countries
Canada, China, United States
Outcome results
None listed