Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 12:55 AM
Study NCT ID:
NCT04882306
Status:
UNKNOWN
Last Update Posted:
2022-05-20
First Post:
2021-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ABC Study: Assessment of Breast Density Classification
Sponsor:
Micrima, Ltd.
Organization:
Study Overview
Official Title:
The ABC Study: Assessment of Breast Density Classification Via Algorithm Development Using Microwave Imaging in Breast Clinics
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: