Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Real World Case Registry Study to Evaluate Augmented Reality Navigation System for Diagnosis of Peripheral Pulmonary Nodules

Conditions
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Lung; Node

Intervention / Treatment
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* Device: Augmented Reality Navigation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18; Chest thin-layer CT show that the peripheral pulmonary nodule (maximum diameter ≤3 cm) is not clearly diagnosed, and planned to be sampled and diagnosed by Augmented Reality Navigation System guided bronchoscopy; The target nodule is evaluated as being able to be reached via bronchoscope under the guidance of Augmented Reality Navigation System before procedure; Patients can understand the study and sign informed consent form. Exclusion Criteria: - 1. Contraindications for bronchoscopy: Myocardial infarction whithin 1 month. Active massive hemoptysis. Coagulation dysfunction. Pregnancy. Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc. 2. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of procedure; 3. The situations in which the investigators consider that patients are not suitable for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br>The patients whose chest CT images show that the pulmonary nodules are highly suspected of malignant and scheduled to be diagnosed by bronchoscopy under the guidance of the Augmented Reality Navigation System. | Device: Augmented Reality Navigation System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system. | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system. | Twelve months | 
| Success rate of biopsy | It is defined as the percentage of nodules with successful biopsy. | 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). | Immediately after Each Operation | 
| Total navigation time | It is defined as the total time from the beginning of navigation to the end of navigation. | Immediately after Each Operation | 
| Bronchoscope operation time | It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal. | Immediately after each operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented Reality Navigation System, Peripheral Pulmonary Nodules, biopsy