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Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer — Phi-Bra  

Breast Neoplasm Female Clinical Trial

Official title:
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer

Clinical Trial Summary

Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography. The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature. The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification). The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography. The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05574816
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase N/A
Start date March 30, 2023
Completion date February 1, 2024
View Details
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