Smart Bra for Diagnosing Breast Cancer (CBRA)

Hopital Nord Franche-Comte

Status: Enrolling

Conditions: Breast Cancer; Medical Device

Treatments: Device: BRA CONNECT device

Study type: Interventional

Funder types: Other

Identifiers

NCT05294016

2021-04

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Patient group

Other group

Treatment:

Device: BRA CONNECT device

Control group

Other group

Treatment:

Device: BRA CONNECT device