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

NCT05857111 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2023-05-12

No results posted yet for this study

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

Interventions

DEVICE

Celbrea

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

Sponsors & Collaborators

  • Welwaze Medical Inc.

    collaborator UNKNOWN

  • Jose Ignacio Sánchez

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2023-07-07
Completion
2023-07-07
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857111 on ClinicalTrials.gov