Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety, feasibility and performance
研究概览
简要总结
This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection.
In consequence the data should also be taken to adapt technical features according to the findings. The study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. In the future pivotal study, the effectiveness of method and the reduction in R1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut.
The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.
After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. During the second visit (V2) they will receive the treatment procedure with the investigational medical device (IMD). The follow up visit (V3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)
- •Solid tumor size ≥ 15 mm at screening, on sonography imaging
- •Breast conserving surgery
- •≥ 18 years of age
- •Ability to provide written informed consent
排除标准
- •Neoadjuvant chemotherapy
- •Bilateral breast conserving surgery
- •Invasive lobular carcinoma, DCIS, LCIS
- •Suspicion of extensive DCIS component of NST tumor
- •Diagnosis of recurrent breast cancer
- •Previous radiotherapy
- •Patient is pregnant or lactating
- •Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator
- •According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation
结局指标
主要结局
Safety, feasibility and performance
时间窗: 11 days
The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.
次要结局
未报告次要终点