Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-28 @ 9:25 PM
Study NCT ID:
NCT05914168
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2022-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Data Collection in Breast Tomosynthesis (COBRIS)
Sponsor:
GE Healthcare
Organization:
Study Overview
Official Title:
Clinical Data Collection in Breast Tomosynthesis: COBRIS
Status:
UNKNOWN
Status Verified Date:
2023-06
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:
COBRIS
Brief Summary:
The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment
Detailed Description:
After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.
Study Oversight
Has Oversight DMC:
False
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?: