Smart Bra for Diagnosing Breast Cancer
Not Applicable
Recruiting
- Conditions
- Medical DeviceBreast Cancer
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does the Smart Bra utilize for breast abnormality detection in cancer screening?
How does the Smart Bra's diagnostic accuracy compare to traditional mammography and ultrasound in breast cancer screening?
Are there specific biomarkers that enhance the Smart Bra's ability to identify early-stage breast cancer subtypes?
What potential adverse events are associated with wearable medical devices like the Smart Bra in long-term cancer monitoring?
What are the key technological innovations in the Smart Bra that differentiate it from other breast cancer diagnostic devices?
Trial Locations
- Locations (2)
ICANS (Institut de Cancérologie de Strasbourg)
🇫🇷Strasbourg, France
Hôpital Nord Franche-Comté
🇫🇷Trevenans, France
ICANS (Institut de Cancérologie de Strasbourg)🇫🇷Strasbourg, FranceCarole MATHELIN, PrContact