Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-18

Study Completion Date

2023-07-07

Brief Summary

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This is an observational, prospective, and transversal study, designed to evaluate the effectiveness of CELBREA® in women from the local community coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt, providing actualized data on the effectiveness of the device within the context of the real-world scenario. Because of its transverse nature, the observation period will be limited to the necessary amount of time to perform the initial consult, additional tests when prescribed by the physician, and the CELBREA® test.

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Detailed Description

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Conditions

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Breast Disease Benign Breast Disease Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study population

An estimate of 255 adult women (≥ 18 years old) who come to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt will be included.

Celbrea

Intervention Type DEVICE

The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.

Interventions

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Celbrea

The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.

Intervention Type DEVICE

Other Intervention Names

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Breast Thermal Activity Indicator

Eligibility Criteria

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Inclusion Criteria

1. Women ≥ 18 years old coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of:

* Discomfort or breast symptoms including, but not limited to, signs or symptoms detected through a self-examination, changes of color or shape in the nipple, nipple discharge, change of appearance or color of breast skin, lumps, etc.
* Refered for evaluation because of diagnostic doubt.
2. Capable of following the instructions necessary for the study.
3. Have signed the informed consent form.

Exclusion Criteria

1. Women who are pregnant or lactating at the time of the study.
2. Women suffering from one of the following breast pathologies:

* Personal history of breast cancer, previous or current.
* Current chemotherapy or radiotherapy for any type of cancer.
* History of breast surgery (reductive, reconstructive, mastectomy, lumpectomy, and others).
* Fever.
* Swelling or local infections on the breasts.
* Open wounds in breast skin.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No