Smart Bra for Diagnosing Breast Cancer | NCT05294016

Studies
Smart Bra for Diagnosing Breast Cancer

NCT05294016

Sponsor

Hopital Nord Franche-Comte

Status

Active, not recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Breast Cancer
Medical Device

Interventions

BRA CONNECT device

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2022Actual

Primary Completion Date

Jul 10, 2025Actual

Completion Date

Aug 28, 2026Estimated

First Submitted Date

Mar 15, 2022

First Submission Date that Met QC Criteria

Mar 15, 2022

First Posted Date

Mar 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient group	Other		Device: BRA CONNECT device
Control group	Other		Device: BRA CONNECT device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BRA CONNECT device	Device	skin thermal analysis for the detection of breast abnormalities	Control group Patient group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICANS (Institut de Cancérologie de Strasbourg)		Strasbourg			France
Hôpital Nord Franche-Comté

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided