A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions

Study Overview
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Brief Summary
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Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.

Official Title
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A Real-World Study to Evaluate the Effectiveness and Safety of Robot-Assisted Bronchoscopy in Chinese Patients With Lung Lesions

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Device: Robot-assisted Bronchoscopy (Monarch Platform)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Robot-assisted Bronchoscopy<br>Participants with 8-50 millimeters (mm) diameter size lung lesions identified on computed tomography (CT) scan will be enrolled for robotic assisted bronchoscopy (Monarch Platform) biopsy procedure. | Device: Robot-assisted Bronchoscopy (Monarch Platform)<br>* Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigation Success Rate | 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. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to R-EBUS Confirmation | 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. | Intraoperative | 
| Time to the Tissue Acquisition | 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). | Intraoperative | 
| Total Procedure Time | Total procedure time is defined by the time the robotic bronchoscope is inserted into the oropharynx until the robotic bronchoscope is removed. | Intraoperative | 
| Number of Conversion to Conventional Bronchoscopic Procedure | 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. | Intraoperative | 
| Number of Participants with Pneumothorax Requiring Intervention | 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. | Up to 7 days post procedure | 
| Number of Participants with Device or Procedure Related Bleeding Requiring Medical Intervention | Number of participants with device or procedure related bleeding requiring medical intervention (rated as >Grade 1 according to the CTCAE scale) will be reported. | Up to 7 days post procedure | 
| Number of Participants with Device or Procedure Related Respiratory Failure | Number of participants with device or procedure related respiratory failure (rated as >Grade 3 according to the CTCAE scale) will be reported. | Up to 7 days post procedure |