A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Percent of Participants With Retrieval of Index Lesion and Magseed
研究概览
简要总结
The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.
详细描述
This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.
Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.
The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.
After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subjects with a breast lesion requiring image-guided localization prior to excision.
- •Subjects aged 18 years or more at the time of consent.
排除标准
- •The subject is pregnant or lactating.
- •Subject has pacemaker or other implantable device in the chest wall.
- •Subject has current active infection at the implantation site in the breast (per investigatordiscretion)
结局指标
主要结局
Percent of Participants With Retrieval of Index Lesion and Magseed
时间窗: Time of surgery on average 16 minutes
Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.
次要结局
- Percentage of Participants With Re-excision(During surgery on average 16 minutes)
- Number of Device Related Adverse Events(8 weeks)
- Surgical Localization - Duration of Localization(At time of surgery on average 16 minutes)
- Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy(At the time of marker deployment on average 8.39 minutes)
- Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion(At time of marker deployment on average 8.39 minutes)
- Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy(At time of surgery on average 16 minutes)
- Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy(On the day of surgery)