The study is designed to evaluate the efficacy and safety of Augmented Reality Navigation System through intra-airway navigation system to guide bronchoscopy in the diagnosis of peripheral pulmonary nodules and explore the factors of diagnosis yield.
This is a single-arm, prospective, Asian multicenter, Real World case Registry study. Recruitment is expected to last up to 12 months, and each subject may be followed up for 12 months at most after surgery which depends on certain factors. The total duration of the study is about 24 months.The research is planned to be carried out at more than 10 sites.
Study Type
OBSERVATIONAL
Enrollment
1,000
Investigators will assess the nodules based on the CT images of subjects before procedure. And then, the appropriate intra-airway path planned by the Augmented Reality Navigation System will be selected. The bronchoscopy with intra-airway navigation under the guidance of the Augmented Reality Navigation System will be performed and the following surgical information will be record.
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, China
Diagnostic yield
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.
Time frame: twelve months
Diagnostic yield
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.
Time frame: Twelve months
Success rate of biopsy
It is defined as the percentage of nodules with successful biopsy.
Time frame: Immediately after Each Operation
Navigation success rate
It is defined as the percentage of nodules whose arrival is confirmed by endobronchial ultrasound (and/or fluoroscopy, or direct bronchoscopy).
Time frame: Immediately after Each Operation
Total navigation time
It is defined as the total time from the beginning of navigation to the end of navigation.
Time frame: Immediately after Each Operation
Bronchoscope operation time
It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.
Time frame: Immediately after each operation
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