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| Name | Class |
|---|---|
| Hong Kong Sanatorium & Hospital | INDUSTRY |
| Shanghai Chest Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Reality Navigation System | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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1. Contraindications for bronchoscopy:
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.
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The patients expected to be enrolled in this study is those whose chest CT images show the pulmonary nodules are highly suspected of malignant and scheduled to be diagnosed by bronchoscopy under the guidance of the Augmented Reality Navigation System.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li, MD,PhD | Contact | 8620-83062896 | lishiyue@188.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Diseases | Guangzhou | Guangdong | 510000 | China |
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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 |