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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05199701
Other study ID # 20-08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 10, 2021
Est. completion date December 1, 2025

Study information

Verified date February 2024
Source Hologic, Inc.
Contact Alexis Cooper
Phone 2818681140
Email Alexis.Cooper@Hologic.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 7500
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 100 Years
Eligibility 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 is wheelchair bound and cannot stand independently - Subject has breast implants, cardiac pacemakers or IV ports in the mammography field of view - Subject previously participated in the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Mammography
Hologic pre-market Mammography

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinically acceptable image quality of the Investigational Device. Questionnaire will be used to measure outcomes 4 years
Primary Mammograms can be safety acquired on the Investigational Device. Will be determined using the AE assessment. 4 years
Secondary The ease of positioning and usability of the Investigational Device. Questionnaire will be used to measure outcomes 4 years
Secondary Subject assessment of comfort of the Investigational Device. Questionnaire will be used to measure outcomes 4 years
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