BENITIONSClinical Trial Intelligence

Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

不适用 已完成 NCT04761055

适应症Breast Screening
分期不适用
申办方Memorial Sloan Kettering Cancer Center
状态已完成
受试者人数300 人
干预(药物)Clinical Breast exam (CBE), iBreastExam device, mammogram
开始日期2021年1月29日
完成日期2025年8月19日
结果公布日2026年7月30日

摘要

This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.

Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results

approximately one month after imaging scan · % of true positive breast lesions

Screening Visits for Breast Cancer0.111 % of true positive breast lesions
Screening Visits for Breast Cancer0.111 % of true positive breast lesions

Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results

approximately one month after imaging scan · % of true negative lesions

Screening Visits for Breast Cancer1.000 % of true negative lesions
Screening Visits for Breast Cancer0.997 % of true negative lesions

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。