NCT07686250招募中2 期
Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Successful Operation Rate (SOR)
研究概览
简要总结
The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.
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
- •Adult females who are 18 years of age or older at time of signing informed consent will be eligible.
- •Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- •Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
排除标准
- •Patients undergoing mastectomy for resection of the targeted lesion.
- •Planned excision of multiple separate sites in the ipsilateral breast.
- •Inability to undergo surgery at Moffitt Cancer Center.
研究组 & 干预措施
SAVI Scout MD Localization
Experimental
Participants undergo image-guided placement of multiple Scout MD reflectors followed by breast-conserving surgery using the device for intraoperative localization.
干预措施: SAVI Scout MD system (Device)
结局指标
主要结局
Successful Operation Rate (SOR)
时间窗: Up to 6 weeks.
Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).
次要结局
未报告次要终点
研究者
研究点 (1)
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