Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-29 @ 7:42 PM
Study NCT ID:
NCT06769594
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next Generation CT System
Sponsor:
GE Healthcare
Organization:
Study Overview
Official Title:
Clinical Feasibility and Evaluation of Silicon Photon Counting CT
Status:
RECRUITING
Status Verified Date:
2025-05
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:
The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.
Detailed Description:
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: