Clinical trial NCT05426213: A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions
Official title: A Real-World Study to Evaluate the Effectiveness and Safety of Robot-Assisted Bronchoscopy in Chinese Patients With Lung Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Neoplasms
Lead sponsor: Auris Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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

Primary outcomes:
measure: Navigation Success Rate
timeFrame: Intraoperative
Secondary outcomes:
measure: Time to R-EBUS Confirmation
timeFrame: Intraoperative
measure: Time to the Tissue Acquisition
timeFrame: Intraoperative
measure: Total Procedure Time
timeFrame: Intraoperative
measure: Number of Conversion to Conventional Bronchoscopic Procedure
timeFrame: Intraoperative
measure: Number of Participants with Pneumothorax Requiring Intervention
timeFrame: Up to 7 days post procedure
measure: Number of Participants with Device or Procedure Related Bleeding Requiring Medical Intervention
timeFrame: Up to 7 days post procedure
measure: Number of Participants with Device or Procedure Related Respiratory Failure
timeFrame: Up to 7 days post procedure
Other outcomes:
Locations:
Study officials:
affiliation: Auris Health, Inc.
name: Auris Health, Inc. Clinical Trial
role: STUDY_DIRECTOR
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