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A painless electronic palpation device takes on the clinical breast exam

NCT ID NCT04761055

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

300 people

The number who actually took part.

Started

Jan 2021

Finished

Aug 2025

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • MSK at Ralph Lauren (All Protocol Activities)

    New York, New York, 10035, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

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