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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05857111
Other study ID # PI-5330
Secondary ID 2022.296
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 18, 2023
Est. completion date July 7, 2023

Study information

Verified date May 2023
Source Instituto de Investigación Hospital Universitario La Paz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 255
Est. completion date July 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Spain Hospital Universitario La Paz Madrid

Sponsors (2)

Lead Sponsor Collaborator
Jose Ignacio Sánchez Welwaze Medical Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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