A Prospective, Single-Arm, Multi-Site, Clinical Evaluation of the SAVI SCOUT® Surgical Guidance System for the Location of Non-Palpable Breast Lesions During Excision
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Success rate of reflector placement
研究概览
简要总结
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI SCOUT has been 510K cleared.
The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable abnormality as localized by radiographic or ultrasound methods. In this study, the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard technique of wire localization.
详细描述
Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical excision, the SAVI SCOUT system will be used to locate the reflector, which will be removed along with the surrounding breast tissue.
Final data analysis will be completed within 1 month after the last patient is treated.
Final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure.
Main Objective: to show that the SAVI SCOUT technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure.
Up to 10 sites and 150 patients will be enrolled.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Patient has a non-palpable breast lesion that requires excision
- •Lesion depth ≤ 3 cm from the skin surface in the supine position
- •Patient is scheduled for excision or BCT at a participating institution
- •Patient is between the ages of 18 and 90 years
- •Patient is female
- •Patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study
- •For lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane Subject
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Patient had a previous ipsilateral breast cancer
- •Patient has multicentric breast cancer
- •Patient has Stage IV breast cancer
- •Patient has been treated with neoadjuvant chemotherapy
- •Patient is pregnant or lactating
- •Exclusion Criteria:
结局指标
主要结局
Success rate of reflector placement
时间窗: intraoperative
How often the reflector can be successfully placed
次要结局
- Amount of tissue excised(Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery)
- Percent of cases with clear margins • Percent of cases requiring a second operation(Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery)