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Trial Title:
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)
NCT ID:
NCT05857111
Condition:
Breast Disease
Benign Breast Disease
Breast Cancer
Conditions: Official terms:
Breast Diseases
Fibrocystic Breast Disease
Conditions: Keywords:
breast symptoms
diagnostic doubt
Celbrea
Breast Thermal Activity Indicator
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Device
Intervention name:
Celbrea
Description:
The test with the CELBREA® device will be added to the routine screening according to the
protocols of the health facility.
Arm group label:
Study population
Other name:
Breast Thermal Activity Indicator
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Start date:
January 18, 2023
Completion date:
July 7, 2023
Lead sponsor:
Agency:
Jose Ignacio Sánchez
Agency class:
Other
Collaborator:
Agency:
Welwaze Medical Inc.
Agency class:
Other
Source:
Instituto de Investigación Hospital Universitario La Paz
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857111
