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

Auris Health

Status: Withdrawn

Conditions: Lung Neoplasms

Treatments: Device: Robot-assisted Bronchoscopy (Monarch Platform)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05426213

EDS202101 (Other Identifier)

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Robot-assisted Bronchoscopy

Other group

Description:

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.

Treatment:

Device: Robot-assisted Bronchoscopy (Monarch Platform)