Effect and Safety of Smart Bra of Peking Union Medical College & Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,141
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
This is a multicenter, prospective clinical study was conducted to evaluate the safety and effectiveness of Xiehe smart bra for breast disease screening in outpatients with breast surgery. According to the patients' wishes and written informed consent, they were randomly assigned to the study group. A total of 2000 patients were expected to be enrolled. The training group: validation group = 1:1.
详细描述
This study is a randomized, open, multicenter clinical study. It will be conducted in Peking Union Medical College Hospital, Shanxi Provincial People's Hospital, Beijing Third Hospital, Zhalantun ZhongMeng hospital, Chongqing Medical University affiliated university town hospital, Shenzhen People's Hospital and other national hospitals. A total of 2000 subjects are expected to participate. The patients in the group wore the device for about 3 minutes, and took photos of 5 breast sites. After that, the artificial intelligence learning was carried out on the photos of the training group. For the photos of the verification group, the algorithm obtained by the training group was compared with the existing artificial intelligence algorithms of ultrasound and molybdenum target. During the follow-up, the safety of the product was evaluated. According to the basic principles of safety and performance of who international general GHTF (sg1-n020r5) medical devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who are going to receive breast ultrasound and molybdenum target in breast surgery clinic;
- •Female patients (18-80 years old);
- •Signed written informed consent approved by the relevant institutional review board (IRB) or independent ethics committee (IEC)
排除标准
- •The subjects were pregnant or lactating;
- •Patients with nipple discharge;
- •Known allergy to bra materials;
- •The patients who had received breast surgery or breast puncture within half a year;
- •Patients with skin diseases.
结局指标
主要结局
Sensitivity
时间窗: baseline
Using ultrasound and / or pathological results as the gold standard, the positive rates of breast diseases (benign breast diseases and malignant breast diseases) detected by smart bra are recorded.
次要结局
- Specificity(baseline)