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Search / Trial NCT05294016

Smart Bra for Diagnosing Breast Cancer

Launched by HOPITAL NORD FRANCHE-COMTE · Mar 15, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is testing a new device called the "Smart Bra," designed to help detect breast abnormalities that could indicate breast cancer. The goal is to see how well this portable and connected device works for screening women for breast cancer. By improving early detection, researchers hope to enhance the way breast cancer is diagnosed and treated.

Women aged 65 to 74 who have been diagnosed with a specific type of breast cancer and have certain imaging results may qualify to participate. To join, participants need to have a tumor that is larger than 1 cm and meet specific size requirements for the study bra. However, women with certain conditions, such as inflammatory breast cancer or a history of breast surgeries, are not eligible. If you join the study, you can expect to wear the Smart Bra during the trial, which will help researchers gather important information about its effectiveness in detecting breast cancer early.

Gender

FEMALE

Eligibility criteria

  • 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

About Hopital Nord Franche Comte

Hospital Nord Franche-Comté is a leading healthcare institution located in the Franche-Comté region of France, dedicated to providing high-quality medical care and advancing clinical research. With a strong emphasis on innovation and patient-centered services, the hospital collaborates with various stakeholders to conduct clinical trials that aim to enhance treatment options and improve health outcomes. Its multidisciplinary team of healthcare professionals and researchers is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the integrity and reliability of trial results while prioritizing patient safety and well-being.

Locations

Trevenans, , France

Trévenans, , France

Strasbourg, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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