Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

NCT ID: NCT04740606

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2023-12-10

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.

Conditions

Lung; Node

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment Group

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.

Augmented Reality Navigation System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Sanatorium & Hospital

INDUSTRY

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

ShiYue Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Shiyue Li, MD,PhD

Role: CONTACT

lishiyue@188.com

8620-83062896

Other Identifiers

20201222

Identifier Type: -

Identifier Source: org_study_id