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Mammography Technology

New Mammography Technology for Breast Cancer Screening

Research Sponsored by Hologic, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Indicated for a screening or diagnostic mammogram or breast biopsy
At least 35 years old
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will test how safe and effective a new breast cancer screening device is, and if it is useful for diagnosis.

Who is the study for?
This trial is for women at least 35 years old who need a mammogram or breast biopsy, regardless of race and ethnicity. It's not for those who may be pregnant, cannot stand independently due to being wheelchair-bound, have breast implants, pacemakers, or IV ports in the area where the mammogram takes pictures, or have been in this study before.Check my eligibility
What is being tested?
The study is testing new mammography technology aimed at improving breast cancer screening and diagnosis. The goal is to determine how safe and effective this new device is compared to current methods.See study design
What are the potential side effects?
Since this trial involves standard mammography procedures with a new device, side effects might include discomfort during the procedure and exposure to low-dose radiation typical of standard mammograms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am due for a mammogram or breast biopsy.
I am at least 35 years old.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinically acceptable image quality of the Investigational Device.
Mammograms can be safety acquired on the Investigational Device.
Secondary outcome measures
Subject assessment of comfort of the Investigational Device.
The ease of positioning and usability of the Investigational Device.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects recommended for biopsyExperimental Treatment1 Intervention
Subjects recommended for biopsy
Group II: Screening SubjectsExperimental Treatment1 Intervention
Screening Subjects
First Studied
Drug Approval Stage
How many patients have taken this drug

Find a Location

Who is running the clinical trial?

Hologic, Inc.Lead Sponsor
46 Previous Clinical Trials
52,607 Total Patients Enrolled

Media Library

Investigational Device (Mammography Technology) Clinical Trial Eligibility Overview. Trial Name: NCT05199701 — N/A
Mammogram Research Study Groups: Screening Subjects, Subjects recommended for biopsy
Mammogram Clinical Trial 2023: Investigational Device Highlights & Side Effects. Trial Name: NCT05199701 — N/A
Investigational Device (Mammography Technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199701 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous centers in the US that are presently testing this clinical trial?

"Currently, 11 sites are hosting this clinical trial. These locations include Louisville, Bel Air and Greensboro; as well as 8 other cities. To reduce travel requirements when participating in the study, it is recommended to select a site closest to you for enrollment."

Answered by AI

Am I able to register for participation in this research endeavor?

"The prerequisites for this trial necessitate that all potential candidates have undertaken mammography and are between the ages of 35 and 100. The maximum number of enrollees is 5400."

Answered by AI

Does the enrollment criteria for this clinical study encompass those who are aged 65 and above?

"This medical examination is inviting individuals who are between 35 years and a century old to participate."

Answered by AI

Are there still vacant positions available for participants in this clinical trial?

"Per the information present on clinicaltrials.gov, this medical trial is currently open for patient recruitment. It was initially announced on December 10th 2021 and details were last modified October 3rd 2022."

Answered by AI

What is the size of the population being sampled for this research endeavor?

"This clinical trial demands 5400 eligible participants in order to move forward. Those that meet the requirements can take part at Baptist Health, Louisville or Progressive Radiology, Bel Air with ease."

Answered by AI

Who else is applying?

What site did they apply to?
Solis Mammography Greensboro
Washington Radiology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~3032 spots leftby Dec 2025