ClinicalTrials.gg
Active, not recruitingNCT05294016CBRAUpdated Feb 27, 2026

Smart Bra for Diagnosing Breast Cancer

An interventional study of BRA CONNECT device in Breast Cancer and Medical Device, sponsored by Hopital Nord Franche-Comte. Active, not recruiting at 2 sites in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Hopital Nord Franche-Comte · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Medical Device

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 70 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hopital Nord Franche-Comte is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-specific invasive carcinoma diagnosed by
  • 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

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
  • History of thoraco-abdominal radiotherapy
  • Known allergy to one of the materials of the device
  • Fever (body temperature > 37.8°C)
  • Pacemaker port
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    Patient group

    Device: BRA CONNECT device

  • Other
    Control group

    Device: BRA CONNECT device

Interventions

  • DeviceBRA CONNECT device

    skin thermal analysis for the detection of breast abnormalities

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 20 minutes of recording

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05294016
Lead sponsor
Hopital Nord Franche-Comte
Responsible party
Sponsor
First posted
Mar 24, 2022
Start date
Apr 13, 2022
Primary completion
Jul 10, 2025
Completion
Aug 28, 2026 (estimated)
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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