Trials / Unknown
UnknownNCT04102722
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
A Prospective, Single-Center, Feasibility Study Assessing the Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Identifying Malignant Breast Lesions as an Adjunct to Mammography
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,333 (estimated)
- Sponsor
- Transonic Imaging, Inc. · Industry
- Sex
- Female
- Age
- 40 Years – 74 Years
- Healthy volunteers
- Accepted
Summary
This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
Detailed description
This is a single-center, prospective, pilot study in which all enrolled subjects will receive the same screening mammography procedures (i.e., 3D mammography plus MUST). Subjects will have between 1 and 4 clinic visits. The number of visits will be based upon the mammography and MUST findings, and whether additional procedures, such as MRI, biopsy, or a repeat MUST are warranted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MUST device | Imaging with MUST device |
Timeline
- Start date
- 2020-01-14
- Primary completion
- 2020-11-01
- Completion
- 2021-11-01
- First posted
- 2019-09-25
- Last updated
- 2020-01-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04102722. Inclusion in this directory is not an endorsement.