A Real World Case Registry Study to Evaluate Augmented Reality Navigation System for Diagnosis of Peripheral Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Contraindications for bronchoscopy:
- •Myocardial infarction whithin 1 month.
- •Active massive hemoptysis.
- •Coagulation dysfunction.
- •Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.
- •Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of procedure;
- •The situations in which the investigators consider that patients are not suitable for this study.
结局指标
主要结局
Diagnostic yield
时间窗: twelve months
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.
次要结局
- Success rate of biopsy(Immediately after Each Operation)
- Bronchoscope operation time(Immediately after each operation)
- Diagnostic yield(Twelve months)
- Navigation success rate(Immediately after Each Operation)
- Total navigation time(Immediately after Each Operation)
研究者
ShiYue Li
Professor
Guangzhou Institute of Respiratory Disease