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

NCT02597452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2020-04-06

Study results available
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Summary

The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.

Conditions

Interventions

DEVICE

intelligent Breast Exam, iBE

A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.

Sponsors & Collaborators

Principal Investigators

  • Ari D Brooks, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-11-01
Completion
2017-12-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02597452 on ClinicalTrials.gov