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

Auris Health, Inc.

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Lung Neoplasms

Interventions

Robot-assisted Bronchoscopy (Monarch Platform)DEVICE

Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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