NCT06597175已完成3 期
A Multi-center, Open-label, Single Arm, Prospective Pivotal Medical Device Clinical Trial to Evaluate Efficacy and Safety of Study Device (ORIGO) That Provides Numerical Data by Measuring the Composition Within Breast Tissue Using Diffusion Optical Spectroscopy Imaging Technology to Assist in the Differential Diagnosis of Breast Tumors in Patients With Breast Lesions
Olive Healthcare5 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Concordance
研究概览
简要总结
This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by both ultrasound and mammography.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 19 years or older
- •ACR BI-RADS Category 3-5 (5th edition, 2023 update)
排除标准
- •Pregnant, potentially pregnant, or currently breastfeeding
- •Calcifications detected on mammography but do not have corresponding lesions identified on ultrasound
- •Biopsy performed on the same breast within 7 days prior to the date of informed consent
- •Significant trauma or scarring at the measurement site, or those suffering from mastitis.
- •Breast implants, electronic medical devices such as pacemakers, or with a space left in the breast cavity due to implant removal
- •History of phototoxic reactions or light sensitivity
结局指标
主要结局
Concordance
时间窗: Through study completion, an average of 6 months
Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects
次要结局
未报告次要终点
研究者
研究点 (5)
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