Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Margin Positivity
研究概览
简要总结
Observational study. The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen.
Prospective Patient Study: 200 consecutive patients
详细描述
Objectives
1.) To collect data throughout clinical patient workflow for evaluation of.
- localization with SmartClip(s)
- negative margin on primary specimen
- specimen assessment
- length of operation
The EnVisio® Navigation System was cleared as a Class II device by the FDA under 510(k) number K183400. The SmartClip® Soft Tissue Marker was cleared by the FDA under 510(k) number K180640.
Principal Investigator will receive monthly EnVisio system data from Company representative on the EnVisio system data collection for procedural cross reference resulting in.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patient has image identifiable lesion.
- •Patient has selected breast conservation therapy IE: lumpectomy +/-radiation therapy, +/- chemotherapy +/- hormonal or targeted therapies. Neoadjuvant chemotherapy is not an exclusion criterion.
- •Patient will be undergoing target tissue localization with the SmartClip
- •Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System.
- •Patient must be age > or = 18 years.
- •Patients unable to provide consent to surgery must have authorized representative provide consent.
排除标准
- •Patients undergoing mastectomy for resection of the targeted lesion.
- •Patient is localized with an alternative method.
- •Patient that are pregnant.
结局指标
主要结局
Margin Positivity
时间窗: Day of Surgery
Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery. Definitive gross pathology results on final margin
次要结局
未报告次要终点