Clinical trial · Interventional
Smart Bra for Diagnosing Breast Cancer
Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
NCT05294016CI-TRIAL-00104248CBRAactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Medical Device | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRA CONNECT device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Patient group
- interventionNames
- Device: BRA CONNECT device
- type
- OTHER
- label
- Control group
- interventionNames
- Device: BRA CONNECT device
Primary outcomes (1)
- measure
- Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
- timeFrame
- 20 minutes of recording
- description
- Sensitivity and specificity of the device to detect a breast abnormality
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.