NCT05199701Active, not recruitingNot Applicable
Prospective Case Collection Study for New Mammography Technologies
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hologic, Inc.
- Enrollment
- 7,500
- Locations
- 29
- Primary Endpoint
- Clinically acceptable image quality of the Investigational Device.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Investigational Mammogram Exam
Experimental
Intervention: Mammography (Device)
Outcomes
Primary Outcomes
Clinically acceptable image quality of the Investigational Device.
Time Frame: 4 years
Questionnaire will be used to measure outcomes
Mammograms can be safety acquired on the Investigational Device.
Time Frame: 4 years
Will be determined using the AE assessment.
Secondary Outcomes
- The ease of positioning and usability of the Investigational Device.(4 years)
- Subject assessment of comfort of the Investigational Device.(4 years)
Investigators
Study Sites (29)
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