Status:
WITHDRAWN
A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions
Lead Sponsor:
Auris Health, Inc.
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05426213
Start Date
July 12 2022
End Date
September 30 2024
Last Update
February 3 2025
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