An interventional study of Mammography in Mammography, sponsored by Hologic, Inc.. Active, not recruiting at 15 sites in United States. Open to female participants aged 35 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Hologic, Inc. · Not applicable, Interventional, and Screening
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.
Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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.
Clinically acceptable image quality of the Investigational Device.
Questionnaire will be used to measure outcomes
Time frame: 4 years
Mammograms can be safety acquired on the Investigational Device.
Will be determined using the AE assessment.
Time frame: 4 years
The ease of positioning and usability of the Investigational Device.
Questionnaire will be used to measure outcomes
Time frame: 4 years
Subject assessment of comfort of the Investigational Device.
Questionnaire will be used to measure outcomes
Time frame: 4 years
Plan to share: No — To protect participant privacy and comply with the IRB. The IRB did not approved the secondary use of IPD at the time the protocol was approved.
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Nov 2026, 58 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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