Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2022-04-13
2025-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Patient group
BRA CONNECT device
skin thermal analysis for the detection of breast abnormalities
Control group
BRA CONNECT device
skin thermal analysis for the detection of breast abnormalities
Interventions
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BRA CONNECT device
skin thermal analysis for the detection of breast abnormalities
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Hopital Nord Franche-Comte
OTHER
Responsible Party
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Locations
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ICANS (Institut de Cancérologie de Strasbourg)
Strasbourg, , France
Hôpital Nord Franche-Comté
Trévenans, , France
Countries
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Central Contacts
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Facility Contacts
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Carole MATHELIN, Pr
Role: primary
Catherine GAY, Pr
Role: primary
Other Identifiers
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2021-04
Identifier Type: -
Identifier Source: org_study_id