Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)
研究概览
简要总结
First Sense Medical®, LLC is a medical device company developing a novel breast cancer screening tester called the First Sense Breast Exam® Tester. This radiation free tester is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. When the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.
详细描述
This study is designed to evaluate the First Sense Breast Exam® test and the analysis by Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. All of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. The First Sense Tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, over the age of 18 years of age.
- •Asymptomatic women and women who are being screened for breast abnormality.
- •Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
- •Not pregnant or breast feeding.
- •Signed Informed consent.
排除标准
- •Subject does not meet inclusion criteria, noted above.
- •Use of niacin or niacin patch.
- •Use of nitroglycerin.
- •Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
- •Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.).
- •History of breast cancer
结局指标
主要结局
Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)
时间窗: Up to 12 months
次要结局
未报告次要终点