Lung; Node
Conditions
Keywords
Augmented Reality Navigation System, Peripheral Pulmonary Nodules, biopsy
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.
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.
Interventions
DEVICEAugmented 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.
Sponsors
Hong Kong Sanatorium & Hospital
Shanghai Chest Hospital
Guangzhou Institute of Respiratory Disease
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18; 2. 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; 3. The target nodule is evaluated as being able to be reached via bronchoscope under the guidance of Augmented Reality Navigation System before procedure; 4. Patients can understand the study and sign informed consent form.
Exclusion criteria
\- 1\. Contraindications for bronchoscopy: 1. Myocardial infarction whithin 1 month. 2. Active massive hemoptysis. 3. Coagulation dysfunction. 4. Pregnancy. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
China
Contacts
Primary ContactShiyue Li, MD,PhD
Outcome results
None listed