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

NCT02762565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2021-08-16

Study results available
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Summary

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.

Conditions

  • Symptomatic Breast Lump

Interventions

DEVICE

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

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Ari Brooks, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-01-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762565 on ClinicalTrials.gov