Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Multiple Pulmonary Nodules

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

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.

Augmented Reality Navigation System

Shiyue Li, MD,PhD

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.

Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

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

It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.

It is defined as the percentage of nodules with successful biopsy.

It is defined as the percentage of nodules whose arrival is confirmed by endobronchial ultrasound (and/or fluoroscopy, or direct bronchoscopy).

It is defined as the total time from the beginning of navigation to the end of navigation.

It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules	NCT04740606	Lung; Node	Augmented Reali...	18 Years -	Guangzhou Institute of Respiratory Disease
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules	NCT04740606	Lung; Node	Augmented Reali...	18 Years -	Guangzhou Institute of Respiratory Disease

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