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NCT03586583 · ClinicalTrials.gov registry record
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
A clinical trial, sponsored by Fujifilm Medical Systems USA.
- Completed
- Registry status
- 600
- Enrollment target
NCT03586583: Completed study, sponsored by Fujifilm Medical Systems USA.
NCT03586583 is a clinical trial that has completed, run by Fujifilm Medical Systems USA. The registered enrollment target is 600 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03586583 has completed, sponsored by Fujifilm Medical Systems USA.
- COMPLETED
- Registry status
- 600 participants
- Enrollment target
Study Summary
The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).
Primary Outcome
For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale: negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive
Interventions
- DEVICE FBP
- DEVICE ISR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2018-06-30 |
| Est. Completion | 2018-11-19 |
What the finished NCT03586583 record still lists
NCT03586583 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which FBP is the first listed.
NCT03586583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03586583 about?
NCT03586583 is a clinical study titled "Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing". The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).
What is the current status of trial NCT03586583?
This trial is currently completed. The enrollment target is 600 participants. The study started on 2018-06-30. Estimated completion is 2018-11-19.
What interventions are being tested in trial NCT03586583?
The interventions under investigation include: FBP (DEVICE), ISR (DEVICE).
Who is sponsoring clinical trial NCT03586583?
This trial is sponsored by Fujifilm Medical Systems USA, which has 13 total clinical trials registered on ClinicalTrials.gov.
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