Mammography
Conditions
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.
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.
Sponsors
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically acceptable image quality of the Investigational Device. | 4 years | Questionnaire will be used to measure outcomes |
| Mammograms can be safety acquired on the Investigational Device. | 4 years | Will be determined using the AE assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ease of positioning and usability of the Investigational Device. | 4 years | Questionnaire will be used to measure outcomes |
| Subject assessment of comfort of the Investigational Device. | 4 years | Questionnaire will be used to measure outcomes |
Countries
United States
Outcome results
None listed