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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

Who can participate

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

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

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
04

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

05

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

06

Study locations

2 sites
  • ICANS (Institut de Cancérologie de Strasbourg)
    Strasbourg, France
  • Hôpital Nord Franche-Comté
    Trévenans, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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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