Clinical trial · Interventional
Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Screening | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Breast exam (CBE) | Other | — | UNRESOLVED |
| iBreastExam device | Device | — | UNRESOLVED |
| mammogram | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening Visits for Breast Cancer
- description
- Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
- interventionNames
- Other: Clinical Breast exam (CBE)
- Device: iBreastExam device
- Diagnostic Test: mammogram
Primary outcomes (2)
- measure
- Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
- timeFrame
- approximately one month after imaging scan
- description
- comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
- measure
- Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patient * Over 18 years of age, able to consent * RLC patients presenting to RLC or BAIC for mammogram and CBE * Asymptomatic and symptomatic patients will be included Exclusion Criteria: * Male patients * Patients under 18 years of age, unable to consent * Pregnant patients * Lactating patients * Non-intact skin
References
Publications (0)
Data not yet available