Status:
COMPLETED
Delphinus SoftVue Prospective Case Collection - ARM 1
Lead Sponsor:
Delphinus Medical Technologies, Inc.
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as ...
Detailed Description
MEDICAL DEVICES: * SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode ultrasound breast imaging, manufactured by Delphinus Medical Technologies. * SoftVue™ with device ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Female
- Any race or ethnicity
- Age 18 or older
- Asymptomatic
- Complete screening FFDM and DBT views
- BI-RADS density composition category c or d
- Willing to comply with protocol and follow-up recommendations as described in consent form, including the next annual screening exam in 12 months
- Exclusion Criteria
- Weight exceeds 350lbs
- Currently pregnant or lactating by patient self-report
- Weeping rash, open wounds, or unhealed sores on the breast
- Bilateral mastectomy
- Unable to lay prone on the scan table for up to 15 minutes
- History of breast cancer diagnosis and/or treatment (chemotherapy, surgery, and/or radiation) in the past 12 months
Exclusion
Key Trial Info
Start Date :
July 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
7409 Patients enrolled
Trial Details
Trial ID
NCT03257839
Start Date
July 31 2017
End Date
July 31 2021
Last Update
September 5 2021
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
USC Keck School of Medicine
Los Angeles, California, United States, 90033
2
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
3
SouthCoast Imaging
Savannah, Georgia, United States, 31406
4
Beaumont Dearborn Breast Care Center
Dearborn, Michigan, United States, 48124