Lung; Node
Conditions
Keywords
Bronchoscopy, Robotic bronchoscopy, Lung cancer, Peripheral lesions
Brief summary
In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.
Detailed description
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. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a robotic assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Interventions
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Sponsors
Auris Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Capable and willing to give informed consent 2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure 3. Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure 4. Lack bleeding disorders
Exclusion criteria
1. Medical contraindication to bronchoscopy 2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT 3. Patients with endobronchial involvement seen on chest CT 4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure 5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study 6. Uncontrolled or irreversible coagulopathy 7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test 8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device or Procedure Related Adverse Events | 24-84 hours post-procedure | Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure. |
| Successful Navigation to Targeted Peripheral Pulmonary Lesions | During the procedure, approximately 1 hour | Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complications Unrelated to Device | 24-84 hours post-procedure | Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure. |
| Time to R-EBUS Confirmation (Lesion Localization) | During the procedure, approximately 1 hour | Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS. |
| Total Procedure Time | During the procedure | Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed. |
| Diagnostic Yield | Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield. | Determined from the results of the bronchoscopy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robotic Assisted Bronchoscopy Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.
Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Robotic Assisted Bronchoscopy |
|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 42 Participants |
| Race/Ethnicity, Customized Ethnicity Not Reported | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 1 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 2 / 55 |
Outcome results
Primary
Number of Participants With Device or Procedure Related Adverse Events
Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Time frame: 24-84 hours post-procedure
Population: 54 patients underwent the robotic bronchoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Bronchoscopy | Number of Participants With Device or Procedure Related Adverse Events | 2 Participants |
Primary
Successful Navigation to Targeted Peripheral Pulmonary Lesions
Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.
Time frame: During the procedure, approximately 1 hour
Population: Radial probe endobronchial ultrasound was available in 53/54 cases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Bronchoscopy | Successful Navigation to Targeted Peripheral Pulmonary Lesions | 51 Participants |
Secondary
Diagnostic Yield
Determined from the results of the bronchoscopy.
Time frame: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.
Population: 54 patients underwent the robotic bronchoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Bronchoscopy | Diagnostic Yield | 40 Participants |
Secondary
Incidence of Complications Unrelated to Device
Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.
Time frame: 24-84 hours post-procedure
Population: 54 patients underwent the robotic bronchoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Bronchoscopy | Incidence of Complications Unrelated to Device | 0 Participants |
Secondary
Time to R-EBUS Confirmation (Lesion Localization)
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.
Time frame: During the procedure, approximately 1 hour
Population: Radial probe endobronchial ultrasound was available in 53/54 cases.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Robotic Assisted Bronchoscopy | Time to R-EBUS Confirmation (Lesion Localization) | 13 Minutes |
Secondary
Total Procedure Time
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.
Time frame: During the procedure
Population: 54 patients underwent the robotic bronchoscopy procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Robotic Assisted Bronchoscopy | Total Procedure Time | 51 Minutes |