Trials / Recruiting
RecruitingNCT05199701
Prospective Case Collection Study for New Mammography Technologies
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7,500 (estimated)
- Sponsor
- Hologic, Inc. · Industry
- Sex
- Female
- Age
- 35 Years – 100 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-10
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2022-01-20
- Last updated
- 2025-09-03
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05199701. Inclusion in this directory is not an endorsement.