Prospective Case Collection Study for New Mammography Technologies

Hologic

Status: Enrolling

Conditions: Mammography

Treatments: Device: Mammography

Study type: Interventional

Funder types: Industry

Identifiers

NCT05199701

20-08

Details and patient eligibility

About

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.

Enrollment: 7,500 estimated patients

Sex: Female

Ages: 35 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7,500 participants in 1 patient group

Investigational Mammogram Exam

Experimental group

Description:

All subjects that are indicated for a screening or diagnostic mammogram or breast biopsy.

Treatment:

Device: Mammography