SmartClipTM是一种经过食品和药物管理局批准的电磁芯片（EMC）定位系统，为软组织病变切除提供三维导航。本研究的目的是分析EMC放射学和手术定位在良性和恶性乳腺病变中的准确性和可行性。本研究是一项机构审查委员会批准的单一机构前瞻性研究，时间从2020年10月到2022年9月，共招募了38名进行乳腺保留手术的妇女，病变在乳房X线摄影（MMG）或超声（US）影像中的直径大于5毫米。影像引导定位和手术切除后，收集了乳腺放射学医师和乳腺外科医生的调查问卷。共收到了9名放射学医师和4名外科医生的76份问卷回复。在86.8%的操作中，部署针和EMC的可见性很高，分别为76.3%。92.1%的操作中，部署过程没有困难。在97.4%的情况下，EMC在部署后的MMG上处于正确位置。发生了三起EMC迁移事例，其中一起距离目标病变1厘米。在97.4%的病例中，目标肿块和EMC位于手术标本内。在标本摄影中，39.5%的EMC距离目标病变中心为0-1毫米，18.4%在2-4毫米内，23.7%在5-10毫米内。所有病例的平均手术室时间为65分钟。一个病例由于控制台故障需要使用超声定位目标。放射科医师成功部署了EMC，并取得了准确的可视化和成功的手术切除，EnVisioTM SmartClipTM系统是一种可复制和准确的良性和恶性乳腺病变定位方法。©2023年。外科肿瘤学学会。

SmartClipTM is a food and drug administration-approved, electromagnetic chip (EMC) localization system that provides three-dimensional navigation for the excision of soft tissue lesions. The purpose of this study was to analyze the accuracy and feasibility of EMC radiologic and surgical localization for benign and malignant breast lesions.An institutional review board-approved, single institution, prospective study from October 2020 to September 2022 of 38 women undergoing breast conserving surgery with EMC localization of a single lesion > 5 mm on mammogram (MMG) or ultrasound (US) imaging. Surveys from performing breast radiologists and breast surgeons were collected after image-guided localization and surgical excision.Seventy-six survey responses from nine radiologists and four surgeons were received. The deployment needle and EMC were highly visible in 86.8% and 76.3% of procedures, respectively. There was no difficulty in deployment for 92.1% of procedures. The EMC was in the correct location on postdeployment MMG in 97.4% of cases. Three instances of EMC migration occurred, one 1 cm from target lesion. The targeted mass and EMC were within the surgical specimen in 97.4% of cases. On specimen radiograph, 39.5% of the EMCs were 0-1 mm from the center of the target lesion, 18.4% were within 2-4 mm, and 23.7% were within 5-10 mm. Mean operating room time for all cases was 65 min. One case required US to localize the target due to console malfunction.There was successful EMC deployment by radiologists with accurate visualization and successful surgical excision in most cases. The EnVisioTM SmartClipTM system is a reproducible and accurate localization method for benign and malignant breast lesions.© 2023. Society of Surgical Oncology.