Trials / Completed
CompletedNCT00759447
A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 240 (actual)
- Sponsor
- Hologic, Inc. · Industry
- Sex
- Female
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
Detailed description
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Genesis and Gemini | 3 dimensional breast mammography system |
| DEVICE | Investigational 3D Mammography system | 3 dimensional breast mammography system |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2008-09-25
- Last updated
- 2019-02-22
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT00759447. Inclusion in this directory is not an endorsement.