Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development: a Prospective, Non-interventional Study (Using CE-marked Bronchoscopes)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Number of bronchial segments accessed during bronchoscopy
研究概览
简要总结
The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.
详细描述
A data collection of bronchoscopy videos from 100-150 patients are enrolled for getting image material of different lung anatomies, captured with CE-marked and FDA-approved Ambu bronchoscopes (Ambu® aScope™ 5 Broncho HD). No intervention will take place, only standard of care. All types of indications are enrolled. All patients were given oral and written information prior to participating, and signed consent was provided. No patient identifiable information is stored.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients indicated for bronchoscopy of central airways as per standard of care
- •Patients of 18 years or above
排除标准
- •Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
- •Patients unable or unwilling to give informed consent
结局指标
主要结局
Number of bronchial segments accessed during bronchoscopy
时间窗: 1 year
Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities
次要结局
未报告次要终点