RecruitingNot ApplicableNCT05199701
Prospective Case Collection Study for New Mammography Technologies
Sponsor
Hologic, Inc.
Enrollment
7,500 participants
Start Date
Dec 10, 2021
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 35 YearsMax Age: 100 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
DEVICEMammography
All subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT05199701