CBRA: Smart Bra for Diagnosing Breast Cancer

• Sponsor: Hopital Nord Franche-Comte (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05294016
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Medical Device	Device: BRA CONNECT device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
• Anticipated Study Start Date: Apr 19, 2022
• Anticipated Primary Completion Date: Oct 19, 2022
• Anticipated Study Completion Date: Nov 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient group	Device: BRA CONNECT device; skin thermal analysis for the detection of breast abnormalities
Other: Control group	Device: BRA CONNECT device; skin thermal analysis for the detection of breast abnormalities

Outcome Measures

Primary Outcome Measures

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. [20 minutes of recording]

   Sensitivity and specificity of the device to detect a breast abnormality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Non-specific invasive carcinoma diagnosed by biopsy

• X-ray images available

• Tumor larger than 2 cm assessed radiologically and/or ultrasound

Exclusion Criteria:

• Contralateral 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Nord Franche-Comté	Trévenans		France	90400

Sponsors and Collaborators

• Hopital Nord Franche-Comte

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Nord Franche-Comte
• ClinicalTrials.gov Identifier: NCT05294016
• Other Study ID Numbers: 2021-04
• First Posted: Mar 24, 2022
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 6, 2022