Status:
UNKNOWN
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Collaborating Sponsors:
Hong Kong Sanatorium & Hospital
Shanghai Chest Hospital
Conditions:
Lung; Node
Eligibility:
All Genders
18+ years
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 n...
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \-
- 1\. Contraindications for bronchoscopy:
- Myocardial infarction whithin 1 month.
- Active massive hemoptysis.
- Coagulation dysfunction.
- Pregnancy.
- 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.
Key Trial Info
Start Date :
December 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 10 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04740606
Start Date
December 10 2021
End Date
December 10 2023
Last Update
December 7 2021
Active Locations (1)
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1
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, China, 510000