Lung Neoplasms
Conditions
Brief summary
Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.
Interventions
DEVICERobot-assisted Bronchoscopy (Monarch Platform)
Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.
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
* Capable and willing to give informed consent * Acceptable candidate for an elective, non-emergency bronchoscopic procedure * Lung lesions suspected of malignancy, between 8-50 millimeters (mm) in diameter size identified on thin slice (0.9-1.25 mm) computed tomography (CT) scan within 14 days, requiring bronchoscopic biopsy for diagnosis * No more than 1 lung lesion will be targeted for robot-assisted bronchoscopy biopsy
Exclusion criteria
Pre-Operative * Participants with pure ground-glass opacity lesions on pre-procedure chest CT * Participants with the target lesion having endobronchial involvement seen on chest CT * Medical contraindications to bronchoscopy and/or anesthesia as assessed by the investigator (such as severe cardiac arrhythmias, severe hypertension, severe cardiopulmonary dysfunction, myocardial infarction, unstable angina pectoris et cetera \[etc\]) precluding safe bronchoscopic procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Navigation Success Rate | Intraoperative | Navigation success rate is defined as the percentage of successful navigation to the targeted lung lesion (lesion localization) as confirmed by radial probe endobronchial ultrasound (R-EBUS) imaging through Monarch Platform during bronchoscopy procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the Tissue Acquisition | Intraoperative | Time to the tissue acquisition is defined by the time the robotic bronchoscope is inserted into the oropharynx until the tissue acquisition is confirmed by the Rapid On-site evaluation (ROSE). |
| Total Procedure Time | Intraoperative | Total procedure time is defined by the time the robotic bronchoscope is inserted into the oropharynx until the robotic bronchoscope is removed. |
| Number of Conversion to Conventional Bronchoscopic Procedure | Intraoperative | Number of conversion to conventional bronchoscopic procedure is defined as the number of procedures converted to other diagnostic modality due to inability of the Monarch platform to complete the intended bronchoscopy. |
| Time to R-EBUS Confirmation | Intraoperative | Time to R-EBUS confirmation is defined by the time from the robotic bronchoscope inserted into the oropharynx to the localization of the targeted lesion confirmed by R-EBUS. |
| Number of Participants with Device or Procedure Related Bleeding Requiring Medical Intervention | Up to 7 days post procedure | Number of participants with device or procedure related bleeding requiring medical intervention (rated as \>Grade 1 according to the CTCAE scale) will be reported. |
| Number of Participants with Device or Procedure Related Respiratory Failure | Up to 7 days post procedure | Number of participants with device or procedure related respiratory failure (rated as \>Grade 3 according to the CTCAE scale) will be reported. |
| Number of Participants with Pneumothorax Requiring Intervention | Up to 7 days post procedure | Number of participants with pneumothorax requiring intervention (rated as greater than \[\>\] Grade 1 according to the Common Terminology Criteria for Adverse Events \[CTCAE\] scale) will be reported. |
Outcome results
None listed