Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01885143 · ClinicalTrials.gov registry record
A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
A clinical trial of Image Correction, sponsored by GE Healthcare.
- Completed
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT01885143: Completed study of Image Correction, sponsored by GE Healthcare.
NCT01885143 is a study of Image Correction that has completed, run by GE Healthcare. The registered enrollment target is 80 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01885143, a study of Image Correction, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Collect 12 clinical DBT cases with MLO and CC views taken from the Senographe Essential to assess whether the DBT in Senographe Essential is of acceptable quality according to FDA criteria following the clinical evaluation instructions described in Section 9 of the guidance document "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System". Assessment will include review of images with and without artifact correction and with and wi
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 |
What the finished NCT01885143 record still lists
NCT01885143 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
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.
NCT01885143 reports a single indexed study location in Michigan.
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.
What interventions are being tested in trial NCT01885143?
The interventions under investigation include: Digital Breast Tomosynthesis (RADIATION).
Who is sponsoring clinical trial NCT01885143?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia