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Prospective Case Collection Study for New Mammography Technologies

NCT05199701 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7500

Last updated 2025-09-03

No results posted yet for this 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.

Conditions

  • Mammography

Interventions

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.

Sponsors & Collaborators

  • Hologic, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199701 on ClinicalTrials.gov