Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

NCT04740606 | Unknown

• 1 other identifier: 20201222
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Node

Keywords

Augmented Reality Navigation System; Peripheral Pulmonary Nodules; biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Diagnostic yield

  Twelve months

• Success rate of biopsy

  Immediately after Each Operation

• Navigation success rate

  Immediately after Each Operation

• Total navigation time

  Immediately after Each Operation

• Bronchoscope operation time

  Immediately after each operation

Study Arms (1)

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

Interventions

Augmented Reality Navigation System 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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18;
• 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;
• The target nodule is evaluated as being able to be reached via bronchoscope under the guidance of Augmented Reality Navigation System before procedure;
• Patients can understand the study and sign informed consent form.

You may not qualify if:

• \. Contraindications for bronchoscopy:
• Myocardial infarction whithin 1 month.
• Active massive hemoptysis.
• Coagulation dysfunction.
• Pregnancy.
• Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.
• \. 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Hong Kong Sanatorium & Hospital: collaborator
• Shanghai Chest Hospital: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, 510000, China

Location

Central Study Contacts

Shiyue Li, MD,PhD

CONTACT

8620-83062896; lishiyue@188.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 5, 2021
• Study Start: December 10, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: December 7, 2021

Record last verified: 2021-11

Locations

CN (1)