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

Sponsor

Jose Ignacio Sánchez (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05857111

Collaborator

Welwaze Medical Inc. (Other)

255

Enrollment

Location

5.6

Anticipated Duration (Months)

45.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Disease Benign Breast Disease Breast Cancer	Device: Celbrea

Study Design

Study Type:

Observational

Anticipated Enrollment :

255 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Observational Prospective Study, to Validate the Effectiveness of CELBREA® Compared to the Detection Results in Symptomatic Women or Those With Diagnostic Doubt (DETECT-BH)

Actual Study Start Date :

Jan 18, 2023

Anticipated Primary Completion Date :

Jul 7, 2023

Anticipated Study Completion Date :

Jul 7, 2023

Arms and Interventions

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 doubt will be included.	Device: Celbrea The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility. Other Names: Breast Thermal Activity Indicator

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 doubt will be included.

Device: Celbrea

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

Other Names:

Breast Thermal Activity Indicator

Outcome Measures

Primary Outcome Measures

Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator. [Through study completion, an average of 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

INCLUSION CRITERIA

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.

Capable of following the instructions necessary for the study.
Have signed the informed consent form.

EXCLUSION CRITERIA:

Women who are pregnant or lactating at the time of the study.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario La Paz	Madrid		Spain	28046

Sponsors and Collaborators

Jose Ignacio Sánchez
Welwaze Medical Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Ignacio Sánchez, Head of Breast Unit - Hospital Universitario La Paz - Madrid - Spain, Instituto de Investigación Hospital Universitario La Paz

ClinicalTrials.gov Identifier:

NCT05857111

Other Study ID Numbers:

PI-5330
2022.296

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Jose Ignacio Sánchez, Head of Breast Unit - Hospital Universitario La Paz - Madrid - Spain, Instituto de Investigación Hospital Universitario La Paz

breast symptoms

diagnostic doubt

Celbrea

Breast Thermal Activity Indicator

Additional relevant MeSH terms:

Breast Diseases

Fibrocystic Breast Disease

Study Results

No Results Posted as of May 12, 2023