Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118996
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-10-31
Brief Title:
Breast 3DUS ABUS System Comparison
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia ABUS System by GE Medical
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment The clinical 2D ultrasound is performed routinely and the research portion of this study will add a few extra 3-D ultrasound images during the procedure The ultrasound imaging laboratory under the direction of Dr Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None