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Could a smart bra help spot breast cancer early?

NCT ID NCT05294016

Diagnosis Sponsor: Hopital Nord Franche-Comte Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a smart bra that measures skin temperature to find breast abnormalities, including cancer. About 70 women with or without breast cancer will wear the device to see how well it detects tumors. If it works, it could offer a simple, portable screening option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BRA CONNECT device (a smart bra that measures skin temperature)
What this could lead to
If successful, this could lead to a non-invasive, portable tool for earlier breast cancer detection, potentially improving screening access.
What could go wrong
This is a small pilot study with only 70 participants, so results may not apply to everyone. The device is still experimental and may not be accurate enough for widespread use.

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

70 people

The number who actually took part.

Started

Apr 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

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

Accepted

You do not need to have the condition being studied to take part.

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: * Non-specific invasive carcinoma diagnosed by biopsy * X-ray images available * Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically * Patient with a breast size compatible with the study bra size Exclusion Criteria: * Contralateral breast cancer * Inflammatory breast cancer * History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling) * History of breast cancer or mastectomy * Presence of dermatological pathology or breast skin ulceration * Hematoma post biopsy * History of thoraco-abdominal radiotherapy * Known allergy to one of the materials of the device * Fever (body temperature \> 37.8°C) * Pacemaker port

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Medical device

Contacts and locations

Locations

  • Hôpital Nord Franche-Comté

    Trévenans, France

  • ICANS (Institut de Cancérologie de Strasbourg)

    Strasbourg, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.