Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules (ANDA)

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Lung; Node

Treatments: Device: Augmented Reality Navigation System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04740606

20201222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

2. Myocardial infarction whithin 1 month.

3. Active massive hemoptysis.

4. Coagulation dysfunction.

5. Pregnancy.

6. Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.

7. 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.

Trial design

1,000 participants in 1 patient group

Treatment Group

Description:

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.

Treatment:

Device: Augmented Reality Navigation System