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A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
NCT01885143 · View on ClinicalTrials.gov ↗
Study Summary
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.
Conditions Studied
Interventions
- RADIATION Digital Breast Tomosynthesis
Study Locations (1)
Michigan
- Beaumont Hospitals — Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01885143
The ClinicalTrials.gov registry entry for NCT01885143 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Image Correction appearing as the primary indexed condition, and to 1 intervention — of which Digital Breast Tomosynthesis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01885143 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01885143 about?
NCT01885143 is a clinical study titled "A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential". Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are...
What is the current status of trial NCT01885143?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2013-08. Estimated completion is 2014-06.
What conditions does trial NCT01885143 study?
This clinical trial studies the following conditions: Image Correction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01885143?
The interventions under investigation include: Digital Breast Tomosynthesis (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01885143?
This trial is sponsored by GE Healthcare, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01885143 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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