A painless electronic palpation device takes on the clinical breast exam
NCT ID NCT04761055
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study compares a handheld device called iBreastExam to the standard clinical breast exam for detecting breast lumps. The iBreastExam uses pressure sensors to create a color map of the breast, highlighting areas that may need further imaging. Researchers will enroll about 300 women undergoing routine mammography to see if the device matches the accuracy of a nurse's manual exam.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iBreastExam device
- What this could lead to
- If the iBreastExam proves as accurate as a manual exam, it could offer a quick, painless, and standardized way to screen for breast abnormalities.
- What could go wrong
- The device may not detect all abnormalities or may flag false positives, leading to unnecessary imaging. This is an early comparison study, not a proof of improved outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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300 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MSK at Ralph Lauren (All Protocol Activities)
New York, New York, 10035, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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