A Clinical Investigation (Multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (Microwave Mammogram) in Breast Lesions Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- MammoWave sensitivity (number of 'true positive' results)
研究概览
简要总结
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.
MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (<1mW) microwave.
The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position.
MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.
详细描述
The maximum number of participants to the clinical investigation will be 600 (for all the sites). The study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.
The primary gol of the clinical study is to assess MammoWave's ability in BL detection.
The study will involve investigational sites in Italy, Germany and Spain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed Informed consent Form
- •Adult ≥ 18 years old
- •Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available.
- •Patients willing to comply with study protocol and recommendations
排除标准
- •Patients who belong to any vulnerable group
- •Patients with implanted electronic devices
- •Patients who have undergone biopsy less than one week before MammoWave scan
- •Patients with nipple piercings (unless they are removed prior to examination)
- •Pregnancy or breastfeeding
研究组 & 干预措施
Single arm
All patients perform standard breast screening and also MammoWave exam.
干预措施: Clinical investigation medical device class IIa marked CE (Device)
结局指标
主要结局
MammoWave sensitivity (number of 'true positive' results)
时间窗: During the procedure
MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard
次要结局
- Sensitivity for each breast density group(During the baseline)
- MammoWave specificity and sensitivity using RadioSpin simulator(During the Baseline)
- MammoWave specificity and sensitivity(During the baseline)
- Sensitivity for patients which had recent mammography(During the baseline)
- Patient satisfaction questionnaire(During the baseline)
- MammoWave sensitivity in BC(During the baseline))