Clinical trial NCT04740606: Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules
Official title: A Real World Case Registry Study to Evaluate Augmented Reality Navigation System for Diagnosis of Peripheral Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung; Node
Keywords: Augmented Reality Navigation System
Peripheral Pulmonary Nodules
biopsy
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Hong Kong Sanatorium & Hospital
name: Shanghai Chest Hospital
First posted: 2021-02-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Diagnostic yield
timeFrame: twelve months
Secondary outcomes:
measure: Diagnostic yield
timeFrame: Twelve months
measure: Success rate of biopsy
timeFrame: Immediately after Each Operation
measure: Navigation success rate
timeFrame: Immediately after Each Operation
measure: Total navigation time
timeFrame: Immediately after Each Operation
measure: Bronchoscope operation time
timeFrame: Immediately after each operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Diseases
state: Guangdong
Study officials:
References: