Effectiveness Validation Of CELBREA® In Symptomatic Women Or With Diagnostic Doubt Of Breast Pathology (DETECT-BH)

Study Overview

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

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.

N/A

Breast Disease
Benign Breast Disease
Breast Cancer

DEVICE: Celbrea

PI-5330
2022.296 (OTHER Identifier) (OTHER: Hospital Universitario La Paz)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-04-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-05-10
First Submitted that Met QC Criteria 2023-05-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-05-12
First Posted (ACTUAL) 2023-05-12	Results First Posted N/A	Last Verified 2023-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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	DEVICE: Celbrea The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.

Participant Group/Arm

Intervention/Treatment

: 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

DEVICE: Celbrea

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

Primary Outcome Measures	Measure Description	Time Frame
Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator.	Detection Result (DR): it is defined as the absence or presence of a breast pathology (benign or malignant). Positive DR: a DR will be labeled as positive (Positive DR) when the presence (diagnosis) of a breast pathology has been verified (benign or malignant). Negative DR: a DR will be labeled as negative (Negative DR) when the absence of breast pathologies has been verified. Significant Reading (CELBREA® test): A difference of 4 columns or more between corresponding segments is considered significant. Non-significant reading (CELBREA® test): a difference of 3 columns or less in any section between corresponding segments is considered non-significant.	Through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
FEMALE

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Welwaze Medical Inc.

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record