Breast CancerCBRANCT05294016
Smart Bra for Diagnosing Breast Cancer
A study testing BRA CONNECT device in people with Breast Cancer and Medical Device, run by Hopital Nord Franche-Comte at 2 sites in France.
Trial summary
This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Medical Device
- What is being tested?
- BRA CONNECT device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Apr 2022to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- History of thoraco-abdominal radiotherapy
- Known allergy to one of the materials of the device
- Fever (body temperature > 37.8°C)
- Pacemaker port
Trial locations and contacts
2 sites in 1 country.
France2 sites
ICANS (Institut de Cancérologie de Strasbourg)
Strasbourg
Hôpital Nord Franche-Comté
Trévenans
About this study
Official title: Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.
- Conditions
- Breast Cancer, Medical Device
- Being tested
- BRA CONNECT device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRA CONNECT deviceDevice
skin thermal analysis for the detection of breast abnormalities
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Other | Not described Receives: Device: BRA CONNECT device |
| Control group | Other | Not described Receives: Device: BRA CONNECT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
Sensitivity and specificity of the device to detect a breast abnormality
Measured: 20 minutes of recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start13 Apr 2022
- Primary completion10 Jul 2025
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294016
- Sponsor's protocol ID
- 2021-04
- Acronym
- CBRA
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
- ClinicalTrials.gov ID
- NCT05294016
- Acronym / sponsor ID
- CBRA / 2021-04
- Conditions
- Breast Cancer, Medical Device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Other | Device: BRA CONNECT device |
| Control group | Other | Device: BRA CONNECT device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRA CONNECT deviceskin thermal analysis for the detection of breast abnormalities | Device | Control group, Patient group |
Primary outcome
Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
Time frame: 20 minutes of recording
Sensitivity and specificity of the device to detect a breast abnormality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRA CONNECT device in people with Breast Cancer and Medical Device, run by Hopital Nord Franche-Comte at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed. (time frame: 20 minutes of recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.