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| ID | Type | Description | Link |
|---|---|---|---|
| 2022.296 | Other Identifier | Hospital Universitario La Paz |
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| Name | Class |
|---|---|
| Welwaze Medical Inc. | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celbrea | Device | The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility. |
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| 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 |
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INCLUSION CRITERIA
Women ≥ 18 years old coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of:
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:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D003550 | Cystic Fibrosis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |