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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04740606
Other study ID # 20201222
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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