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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung; Node
• Intervention / Treatment: Device: Augmented Reality Navigation System

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Shiyue Li, MD,PhD; Phone Number: 8620-83062896; Email: lishiyue@188.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou Institute of Respiratory Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients expected to be enrolled in this study is those whose chest CT images show the pulmonary nodules are highly suspected of malignant and scheduled to be diagnosed by bronchoscopy under the guidance of the Augmented Reality Navigation System.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Collaborators: Shanghai Chest Hospital; Hong Kong Sanatorium & Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 10, 2021
• Primary Completion (Anticipated): December 10, 2023
• Study Completion (Anticipated): December 10, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: biopsy; Augmented Reality Navigation System; Peripheral Pulmonary Nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: 20201222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No