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Clinical Trials in the USA / NCT05199701
Active, not recruiting Not applicable

Prospective Case Collection Study for New Mammography Technologies

NCT05199701 · tracked via the Priya Life Science USA tracker
Sponsor
Hologic, Inc
Phase
Not applicable
Started
2021-12-10
Last updated
2026-06-22

Condition(s) studied

Mammography

Investigational drug(s) / intervention(s)

Mammography

Mammography: All subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device.

Study summary

To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.

Eligibility

Sex
FEMALE
Min age
35 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Subject is female of any race and ethnicity. * Subject is at least 35 years old. * Subject is indicated for a screening or diagnostic mammogram or breast biopsy. Exclusion Criteria: * Subject is pregnant or thinks she may be pregnant * Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view. * Subject previously participated in the study.

Primary outcome measure(s)

  • Clinically acceptable image quality of the Investigational Device. — 4 years
    Questionnaire will be used to measure outcomes
  • Mammograms can be safety acquired on the Investigational Device. — 4 years
    Will be determined using the AE assessment.

Trial sites (15)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Southwest Medical Imaging Gilbert Arizona
Scottsdale Medical Imaging LTD Scottsdale Arizona
Miami Breast Institute Coral Gables Florida
Diagnostic Centers of America Palm Beach Gardens Palm Beach Gardens Florida
Diagnostic Centers of America West Palm Beach West Palm Beach Florida
Baptist Health Louisville Kentucky
Progressive Radiology Bel Air Maryland
Corewell Health Grand Rapids Michigan
Elizabeth Wendy Breast Care Rochester New York
Solis Mammography Greensboro Greensboro North Carolina
Solis Mammography Columbus Columbus Ohio
Solis Mammography Burleson Burleson Texas
Washington Radiology Arlington Virginia
Washington Radiology Sterling Virginia

More Hologic, Inc. trials in the USA

Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05199701 on ClinicalTrials.gov ↗ ← All trials in the USA