Prospective Case Collection Study for New Mammography Technologies
- Conditions
- Mammography
- Interventions
- Device: Mammography
- Registration Number
- NCT05199701
- Lead Sponsor
- Hologic, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 7500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects recommended for biopsy Mammography Subjects recommended for biopsy Screening Subjects Mammography Screening Subjects
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method The ease of positioning and usability of the Investigational Device. 4 years Questionnaire will be used to measure outcomes
Subject assessment of comfort of the Investigational Device. 4 years Questionnaire will be used to measure outcomes
Trial Locations
- Locations (14)
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Southwest Medical Imaging
🇺🇸Gilbert, Arizona, United States
Scottsdale Medical Imaging LTD
🇺🇸Scottsdale, Arizona, United States
Miami Breast Institute
🇺🇸Coral Gables, Florida, United States
Diagnostic Centers of America Palm Beach Gardens
🇺🇸Palm Beach Gardens, Florida, United States
Diagnostic Centers of America West Palm Beach
🇺🇸West Palm Beach, Florida, United States
Baptist Health
🇺🇸Louisville, Kentucky, United States
Progressive Radiology
🇺🇸Bel Air, Maryland, United States
Elizabeth Wendy Breast Care
🇺🇸Rochester, New York, United States
Solis Mammography Greensboro
🇺🇸Greensboro, North Carolina, United States
Solis Mammography Columbus
🇺🇸Columbus, Ohio, United States
Solis Mammography Burleson
🇺🇸Burleson, Texas, United States
Washington Radiology
🇺🇸Sterling, Virginia, United States