A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Number of Participants With Technical Success
研究概览
简要总结
Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contrast Biopsy will provide an additional solution to biopsy/localize lesions found by using a CEDM imaging modality.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities
- •Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them
排除标准
- •Subjects who require a Legally Authorized Representative (LAR) for Informed Consent
- •Subjects who, based on the physician's judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders
- •Subjects who have had a previous allergic reaction to IV contrast agent
研究组 & 干预措施
Affirm Contrast Biopsy
Women 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities
干预措施: Affirm Contrast Biopsy procedure (Device)
结局指标
主要结局
Number of Participants With Technical Success
时间窗: Up to 1h (time to complete the procedure)
Technical success was defined as successfully completing the breast biopsy procedure with the Affirm Contrast Biopsy system for each participant (60 participants equals 60 procedures).
次要结局
未报告次要终点