A Prospective, Multicenter, Post Market Study to Collect Data for Software Recognizing the Anatomical Structures as Well as Abnormalities in the Lung During a Bronchoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 833
- 试验地点
- 1
- 主要终点
- Number of anatomical 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
2.000 subjects, preferable 150-200 number of patients per site. The 2.000 videos will be divided into an 80%/20% split (training and testing). It is a wish to obtain a spread of videos coming from across Europe, preferable from Germany, France and Denmark, with up to 800 videos coming from Denmark
The patient population indicated are patients indicated for full airway bronchoscopy. Of this group it is the aim to enrol the following:
- Patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies
- Bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies
- Patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies.
- Patients with former lung operations, partial or full resections - no more than 2% (48 patients).
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
- •Oral and written participant information has been given (NA for Denmark)
- •The subject has signed informed consent (NA for Denmark)
- •Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
- •Patients older than 18
排除标准
- •Subject with serious lung disease which investigator considers not appropriate for this examination.
- •Lack of patient cooperation for bronchoscopy (patient with mental disorders, dysgnosia, psychological disorder...)
- •Subjects unable to give consent (NA for Denmark)
结局指标
主要结局
Number of anatomical segments accessed during bronchoscopy
时间窗: 1 day
accurate photo documentation of all 18 anatomical segments +/- abnormalities
次要结局
- Rate of total number of lesions detected(1 day)
- Number of anatomical segments identified(1 day)
- Number of sections and lesions detected by core lab and machine learning(1 day)