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Recruiting NCT05199701
Prospective Case Collection Study for New Mammography Technologies
Trial Parameters
Condition Mammography
Sponsor Hologic, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 7,500
Sex FEMALE
Min Age 35 Years
Max Age 100 Years
Start Date 2021-12-10
Completion 2026-03-31
Interventions
Mammography
Brief Summary
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.
Eligibility Criteria
Inclusion Criteria: * Subject is female of any race and ethnicity. * Subject is at least 35 years old. * Subject is indicated for a screening or diagnostic mammogram or breast biopsy. Exclusion Criteria: * Subject is pregnant or thinks she may be pregnant * Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view. * Subject previously participated in the study.