Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
研究概览
简要总结
This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
- •Participants must be age > or = 18 years.
排除标准
- •Participants with sonographically or mammographically occult target lesions
- •Participants with greater than 35cm chest to bust depth
- •Participants undergoing mastectomy for resection of the targeted lesion
- •Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines
- •Patients requiring use of more than 3 SmartClips to localize targets
研究组 & 干预措施
Participants receiving SmartClip
Participants will undergo a preoperative physical exam and at least one preoperative ultrasound demonstrating the mass for resection. The SmartClip will be placed under ultrasound guidance. Post-placement mammogram will be obtained after placement of the clip. The SmartClip can be placed up to 30 days prior to the planned surgical resection. At the time of definitive surgery, the Envisio system will be used to identify the clip and the targeted lesion for resection. Intraoperatively, a specimen radiograph will be performed to confirm the presence of the SmartClip and the targeted lesion in the surgical specimen. The breast surgical specimen will be sent for gross examination, including measurements of the tumor in 3 axes. Immediately post-procedure, the performing surgeon will fill out a questionnaire to determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery.
干预措施: EnVisio SmartClip (Device)
Participants receiving SmartClip
Participants will undergo a preoperative physical exam and at least one preoperative ultrasound demonstrating the mass for resection. The SmartClip will be placed under ultrasound guidance. Post-placement mammogram will be obtained after placement of the clip. The SmartClip can be placed up to 30 days prior to the planned surgical resection. At the time of definitive surgery, the Envisio system will be used to identify the clip and the targeted lesion for resection. Intraoperatively, a specimen radiograph will be performed to confirm the presence of the SmartClip and the targeted lesion in the surgical specimen. The breast surgical specimen will be sent for gross examination, including measurements of the tumor in 3 axes. Immediately post-procedure, the performing surgeon will fill out a questionnaire to determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery.
干预措施: EnVisio™ Navigation System (Device)
Radiologist Placing SmartClip
Radiologist will place SmartClip under ultrasound guidance. A Post-placement mammogram will be obtained after placement of the SmartClip. Immediately post-procedure, the performing radiologist will fill out a questionnaire.
干预措施: EnVisio SmartClip (Device)
Radiologist Placing SmartClip
Radiologist will place SmartClip under ultrasound guidance. A Post-placement mammogram will be obtained after placement of the SmartClip. Immediately post-procedure, the performing radiologist will fill out a questionnaire.
干预措施: EnVisio™ Navigation System (Device)
Surgeon
The surgeon will use the EnVisio™ Navigation System to identify the SmartClip and the targeted lesion for resection. Immediately post-procedure, the performing surgeon will fill out a questionnaire
干预措施: EnVisio SmartClip (Device)
Surgeon
The surgeon will use the EnVisio™ Navigation System to identify the SmartClip and the targeted lesion for resection. Immediately post-procedure, the performing surgeon will fill out a questionnaire
干预措施: EnVisio™ Navigation System (Device)
结局指标
主要结局
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
时间窗: 1 year
Questions 1,2,5,6,7 \& 8 from the Radiologist survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort
时间窗: 1 year
Questions 4, 5, 6, 8, 9, 10, \& 11 from the Surgeon survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
次要结局
- Placement of the SmartClip on preoperative imaging to clip location on specimen radiography(1 year)
- Placement and visibility of the clip by breast radiologists(1 year)
- Intraoperative use of the device system by surgeons(1 year)
- Surgical outcomes with use of the SmartClip(1 year)