Clinical Utility of a Low-Cost Hand-Held Breast Scanner

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

Brief Summary

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Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.

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Detailed Description

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Conditions

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Symptomatic Breast Lump

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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breast scanner

Group Type EXPERIMENTAL

PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

Intervention Type DEVICE

Interventions

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PEFS system (Product Name: Intelligent Breast Exam™ or iBE™

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Women and men with symptomatic breast lump (either by palpation or imaging) OR
* Asymptomatic women presenting to the imaging center for a screening mammogram.
* Signed Informed Consent

Exclusion Criteria

* Patients under 18 years of age
* Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No