Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

• Conditions: Lung; Node
• Interventions: Device: Augmented Reality Navigation System

• Registration Number: NCT04740606
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-12-07
• Study Start: 2021-12-10
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	Augmented Reality Navigation System	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Success rate of biopsy	Immediately after Each Operation	It is defined as the percentage of nodules with successful biopsy.
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.
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.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Diseases; 🇨🇳 Guangzhou, Guangdong, China