NCT05294016

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
3mo left

Started Apr 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2022Aug 2026

First Submitted

Initial submission to the registry

March 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

March 15, 2022

Last Update Submit

February 24, 2026

Conditions

Breast CancerMedical Device

Outcome Measures

Primary Outcomes (1)

  • Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.

    Sensitivity and specificity of the device to detect a breast abnormality

    20 minutes of recording

Study Arms (2)

Patient group

OTHER
Device: BRA CONNECT device

Control group

OTHER
Device: BRA CONNECT device

Interventions

BRA CONNECT deviceDEVICE

skin thermal analysis for the detection of breast abnormalities

Control groupPatient group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ICANS (Institut de Cancérologie de Strasbourg)

Strasbourg, France

Location

Hôpital Nord Franche-Comté

Trévenans, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 24, 2022

Study Start

April 13, 2022

Primary Completion

July 10, 2025

Study Completion (Estimated)

August 28, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)