IGAR-Breast Teleoperative Clinical Investigation
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- ability for IGAR-Breast to perform breast biopsies teleoperatively
研究概览
简要总结
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.
详细描述
In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI
排除标准
- •Subjects who refuse or are unable to give free and informed consent Subjects requiring more than one breast biopsy Subjects with breast implants or other foreign bodies Subjects for whom investigator determines IGAR-Breast enabled MRI-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) Subjects who are pregnant or who plan to become pregnant during the course of the study
研究组 & 干预措施
Patients
IGAR-Breast TeleOp
干预措施: IGAR-Breast TeleOp (Device)
结局指标
主要结局
ability for IGAR-Breast to perform breast biopsies teleoperatively
时间窗: at time of sampling and pathological evaluation
analyzing the frequency of successful biopsy, in which the samples collected are of diagnostic quality as determined by radiologist
次要结局
- number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy(During procedure)