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Clinical Trials in France / NCT05294016
Active, not recruiting Not applicable

Smart Bra for Diagnosing Breast Cancer

NCT05294016 · tracked via the Priya Life Science France tracker
Sponsor
Hopital Nord Franche-Comte
Phase
Not applicable
Started
2022-04-13
Last updated
2026-02-27

Condition(s) studied

Breast CancerMedical Device

Investigational drug(s) / intervention(s)

BRA CONNECT device

BRA CONNECT device: skin thermal analysis for the detection of breast abnormalities

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed. — 20 minutes of recording
    Sensitivity and specificity of the device to detect a breast abnormality

Trial sites (2)

FacilityCityRegionStatus
ICANS (Institut de Cancérologie de Strasbourg) Strasbourg France
Hôpital Nord Franche-Comté Trévenans France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05294016 on ClinicalTrials.gov ↗ ← All trials in France