Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Retrieval rate of the HydroMARK Plus clip.
研究概览
简要总结
The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.
详细描述
Study objectives
Primary objective
Assess the successful retrieval rates of the HydroMARK Plus clip
Secondary objective
Determine the level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy clips scheduled for surgery with SCOUT localization
排除标准
- •Patients who didn't have surgery, patients younger than 18 years old
- •Patients older than 90 years old
- •Non-English speakers
结局指标
主要结局
Retrieval rate of the HydroMARK Plus clip.
时间窗: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
The primary endpoint of HydroMARK Plus retrieval rate will be estimated with % and two-sided 95% CI using normal approximation. A paired McNemar Test will be used to compare HydroMARK Plus retrieval rate and HydroMARK retrieval rate, and the 95% CI for the difference of retrieve rate will be estimated using the Newcombe's Score method.
次要结局
- Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.(Date of retrieval surgery to 1 week.)
研究者
Ceren Yalniz
Assistant Professor
University of Alabama at Birmingham