DRKS00008916
Completed
未知
Philips Digital Breast Tomosynthesis trial for CE markets
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- C50.9
- Sponsor
- Philips Digital Mammography Sweden AB
- Enrollment
- 38
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is female and 40 years of age or older
- •\- Patient will be undergoing a biopsy for a screening\-detected abnormality or after presenting with clinical symptoms (e g palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)
- •\- Patient underwent a 2D mammography (FFDM) in this institution with a Philips MicroDose SI L50 or Philips MicroDose L30 system less than 30 days prior to the day of imaging with the investigational device
Exclusion Criteria
- •\- Patient is pregnant or believes she may be pregnant; OR,
- •\- Patient is breast feeding; OR
- •\- Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR
- •\- Patient has been part of another clinical trial within last 12 months
Outcomes
Primary Outcomes
Not specified
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