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NCT00999596 · ClinicalTrials.gov registry record
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
A clinical trial, sponsored by Philips Healthcare.
- Completed
- Registry status
- 107
- Enrollment target
NCT00999596: Completed study, sponsored by Philips Healthcare.
NCT00999596 is a clinical trial that has completed, run by Philips Healthcare. The registered enrollment target is 107 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00999596 has completed, sponsored by Philips Healthcare.
- COMPLETED
- Registry status
- 107 participants
- Enrollment target
Study Summary
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography. Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.
Primary Outcome
6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-09 |
What the finished NCT00999596 record still lists
NCT00999596 is an observational study that tracks outcomes without assigning an intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00999596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00999596 about?
NCT00999596 is a clinical study titled "Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)". The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography. Per the new FDA Guidance document for FFDM, acc...
What is the current status of trial NCT00999596?
This trial is currently completed. The enrollment target is 107 participants. The study started on 2010-04. Estimated completion is 2011-09.
Who is sponsoring clinical trial NCT00999596?
This trial is sponsored by Philips Healthcare, which has 10 total clinical trials registered on ClinicalTrials.gov.
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