Smart Bra for Diagnosing Breast Cancer

Last updated: December 23, 2024
Sponsor: Hopital Nord Franche-Comte
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

BRA CONNECT device

Clinical Study ID

NCT05294016
2021-04
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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/orclinically

  • Patient with a breast size compatible with the study bra size

Exclusion

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

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: BRA CONNECT device
Phase:
Study Start date:
April 13, 2022
Estimated Completion Date:
November 28, 2025

Connect with a study center

  • ICANS (Institut de Cancérologie de Strasbourg)

    Strasbourg,
    France

    Site Not Available

  • Hôpital Nord Franche-Comté

    Trevenans,
    France

    Active - Recruiting

  • Hôpital Nord Franche-Comté

    Trévenans, 90400
    France

    Site Not Available

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