Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 5:31 PM
Study NCT ID:
NCT04495634
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Purpose: The purpose of this study is to evaluate stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma.
Participants: Participants will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head.
Procedures (methods): This investigation will be a single arm, prospective clinical trial. Participants will have one single visit, which will include the s-HCT scan. No follow-up is required. All images will be de-identified before inclusion within a reader study. The investigators will perform a reader study with physician readers comparing the acquired imaging s-HCT images and conventional head CT.
Participants: Participants will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head.
Procedures (methods): This investigation will be a single arm, prospective clinical trial. Participants will have one single visit, which will include the s-HCT scan. No follow-up is required. All images will be de-identified before inclusion within a reader study. The investigators will perform a reader study with physician readers comparing the acquired imaging s-HCT images and conventional head CT.
Detailed Description:
This investigation will be a single arm, prospective clinical trial evaluating stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma. The investigators hypothesize that a stationary head CT (s-HCT) system based on the carbon nanotube linear array x-ray source can provide diagnostic quality head CT images. Patients included in the study will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| W81XWH1820043 | OTHER_GRANT | United States Department of Defense | View |