NCT05574816

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Neoplasm Female

Interventions

Type	Name	Description
DEVICE	Phi-Bra prototype measurements	The bra prototype will be placed on the patient's breast. The patient will stay in a half-lying position during 15 min, the time duration of the measurements. Measurements will not be painful. Measurements will only be realized one time during the first and unique visit of the patient.

Timeline

• Start date: 2023-03-30
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-10-12
• Last updated: 2024-06-12

Locations

2 sites across 1 country: France