Smart Bra for Diagnosing Breast Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Medical Device Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ICANS (Institut de Cancérologie de Strasbourg), Strasbourg, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRA CONNECT device

Device

skin thermal analysis for the detection of breast abnormalities

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA

Acronym: CBRA

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Mar 24, 2022
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting