Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

Lung; Node Clinical Trial

— ANDA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04740606
• Other study ID #: 20201222
• Status: Not yet recruiting
• Start date: December 10, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: November 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Shiyue Li, MD,PhD
• Phone: 8620-83062896
• Email: lishiyue[@]188.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung; Node
• Multiple Pulmonary Nodules

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Diseases	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Hong Kong Sanatorium & Hospital, Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Success rate of biopsy	It is defined as the percentage of nodules with successful biopsy.	Immediately after Each Operation
Secondary	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
Secondary	Total navigation time	It is defined as the total time from the beginning of navigation to the end of navigation.	Immediately after Each Operation
Secondary	Bronchoscope operation time	It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.	Immediately after each operation