Smart Bra for Diagnosing Breast Cancer
Not Applicable
Recruiting
- Conditions
- Medical DeviceBreast Cancer
- Interventions
- Device: BRA CONNECT device
- Registration Number
- NCT05294016
- Lead Sponsor
- Hopital Nord Franche-Comte
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient group BRA CONNECT device - Control group BRA CONNECT device -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hôpital Nord Franche-Comté
🇫🇷Trevenans, France
ICANS (Institut de Cancérologie de Strasbourg)
🇫🇷Strasbourg, France