ANDA: Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Augmented Reality Navigation System
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.
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Outcome Measures
Primary Outcome Measures
- Diagnostic yield [twelve months]
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.
Secondary Outcome Measures
- Diagnostic yield [Twelve months]
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.
- Success rate of biopsy [Immediately after Each Operation]
It is defined as the percentage of nodules with successful biopsy.
- Navigation success rate [Immediately after Each Operation]
It is defined as the percentage of nodules whose arrival is confirmed by endobronchial ultrasound (and/or fluoroscopy, or direct bronchoscopy).
- Total navigation time [Immediately after Each Operation]
It is defined as the total time from the beginning of navigation to the end of navigation.
- Bronchoscope operation time [Immediately after each operation]
It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18;
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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;
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The target nodule is evaluated as being able to be reached via bronchoscope under the guidance of Augmented Reality Navigation System before procedure;
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Patients can understand the study and sign informed consent form.
Exclusion Criteria:
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Contraindications for bronchoscopy:
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Myocardial infarction whithin 1 month.
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Active massive hemoptysis.
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Coagulation dysfunction.
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Pregnancy.
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Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangzhou Institute of Respiratory Diseases | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Guangzhou Institute of Respiratory Disease
- Hong Kong Sanatorium & Hospital
- Shanghai Chest Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20201222