RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of the patients satisfaction
研究概览
简要总结
The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.
详细描述
It is an observational, prospective, single-center, 2-arm (RFID group vs. standard gold), non-randomized and category 3 comparative study. The RFID trial focuses on breast localization in patients with non-palpable breast cancers. These patients will benefit from a mastology consultation: consent will then be acquired. The RFID tag or the gold standard localization will be put in place during this consultation (one day before surgery).
Patients will fill in their questionnaire in two steps:
- during the installation of the device (RFID tag or wire localization) to evaluate the patient's pain,
- then at the 1-month post-operative consultation to assess pain in the interval until surgery Radiologists and surgeons will fill out the questionnaire dedicated to them after each procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients 18 years of age or older,
- •Requiring conservative surgical management for a breast lesion -infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology.
- •Patients referred to mastology for preoperative identification by the surgeons
- •Able to give informed consent to participate in the research.
- •Affiliation to a Social Security regime
排除标准
- •Multiple breast lesions
- •Patients with breast neoplasia during pregnancy.
- •Person deprived of liberty or under guardianship or incapable of giving consent
- •Refusal to participate
结局指标
主要结局
Evaluation of the patients satisfaction
时间窗: 1 years and 1 month
The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction)
次要结局
- Evaluation of the quality of the RFID tag device by analizing surgery data(1 years and 1 month)
- Satisfaction of surgeons and radiologists assessed by a questionnaire(1 years and 1 month)