Status:
RECRUITING
Smart Bra for Diagnosing Breast Cancer
Lead Sponsor:
Hopital Nord Franche-Comte
Conditions:
Breast Cancer
Medical Device
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05294016
Start Date
April 13 2022
End Date
November 28 2025
Last Update
December 27 2024
Active Locations (2)
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1
ICANS (Institut de Cancérologie de Strasbourg)
Strasbourg, France
2
Hôpital Nord Franche-Comté
Trévenans, France