NCT05857111

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 255 (estimated)
• Sponsor: Jose Ignacio Sánchez · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Disease
• Benign Breast Disease
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Celbrea	The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.

Timeline

• Start date: 2023-01-18
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2023-05-12
• Last updated: 2023-05-12

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study