NCT05294016招募中不适用
Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
研究概览
简要总结
This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-specific invasive carcinoma diagnosed by biopsy
- •X-ray images available
- •Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically
- •Patient with a breast size compatible with the study bra size
排除标准
- •Contralateral breast cancer
- •Inflammatory breast cancer
- •History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling)
- •History of breast cancer or mastectomy
- •Presence of dermatological pathology or breast skin ulceration
- •Hematoma post biopsy
- •History of thoraco-abdominal radiotherapy
- •Known allergy to one of the materials of the device
- •Fever (body temperature > 37.8°C)
- •Pacemaker port
结局指标
主要结局
Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
时间窗: 20 minutes of recording
Sensitivity and specificity of the device to detect a breast abnormality
次要结局
未报告次要终点
研究者
研究点 (2)
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