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Search / Trial NCT03257839

Delphinus SoftVue Prospective Case Collection - ARM 1

Launched by DELPHINUS MEDICAL TECHNOLOGIES, INC. · Aug 18, 2017

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Trial Information

Current as of May 06, 2025

Completed

Keywords

Soft Vue Dense Breast Tissue Breast Screening Abnormal Breast Normal Breast Breast Imaging Breast Biopsy Mammography Tomosynthesis Automated Breast Ultrasound Breast Cancer Breast Carcinoma Breast Tumors Mammary Carcinoma Malignant Breast Tumor Mammary Neoplasm Mammary Cancer Abus Awbus Breast Tomography Atus Abtus Mammogram 3 D Mammogram 3 D Abus 3 D Breast Ultrasound Dbt Ffdm Digital Mammography Breast Ultrasound Dense Breasts Breast Density Dense Parenchyma Asymptomatic Delphinus Delphinus Medical Technologies Screening Breast Ultrasound

ClinConnect Summary

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 modifications (software, hardware, user-interface), safety-tested for human use to complete feasibility, verification, and validation testing as a routine part of product development and performed in accordance with FDA 21 CFR 812.2 (b), manufactured by Delphinus Medical Technologies.
* Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis, various manufacturers...

Gender

FEMALE

Eligibility criteria

  • • 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

About Delphinus Medical Technologies, Inc.

Delphinus Medical Technologies, Inc. is a pioneering medical device company dedicated to transforming breast imaging through innovative technologies. With a focus on improving patient outcomes and enhancing the accuracy of breast cancer detection, Delphinus has developed a proprietary ultrasound-based imaging system that utilizes a unique technology called SoftVue™. This approach provides comprehensive imaging of breast tissue, offering a non-invasive and effective alternative to traditional mammography. Committed to advancing the field of medical imaging, Delphinus Medical Technologies prioritizes research, clinical trials, and collaborations that support the ongoing development of safe, efficient, and patient-centered solutions in women's health.

Locations

Miami Beach, Florida, United States

Detroit, Michigan, United States

Los Angeles, California, United States

Rochester, New York, United States

Pittsburgh, Pennsylvania, United States

Savannah, Georgia, United States

Dearborn, Michigan, United States

Washington, Missouri, United States

Chapel Hill, North Carolina, United States

Appleton, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Mary W Yamashita, MD

Principal Investigator

Keck School of Medicine, University of Southern California

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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