CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 516 enrolled
Drug / intervention
intelligent Breast Exam, iBEdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02597452
NCT02597452N/ACompleted
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Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

University of Pennsylvania·interventional·Posted Nov 5, 2015·Updated Apr 6, 2020

In Brief

A clinical study evaluating intelligent Breast Exam, iBE for Breast Cancer. Completed, enrolled 516 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsUE LifeSciences Inc.

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2015
Enrollment StartMar 1, 2014
Primary CompletionNov 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.7 years ago

Interventions

intelligent Breast Exam, iBEdevice

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.