N/A
N=17
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Head Trauma
Bottom Line
View on ClinicalTrials.gov: NCT04495634 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Sensitivity of Stationary Head CT for the Detection of a Hemorrhage — 33 percent accurately predicted — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stationary Head CT (s-HCT) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Stationary Head CT for the Detection of a Hemorrhage |
33 | <0.0001 sig |
| PRIMARY Specificity of Stationary Head CT for the Detection of a Hemorrhage |
98 | 0.41 |
| PRIMARY Sensitivity of Stationary Head CT for the Detection of a Fracture |
32 | 0.0001 sig |
| PRIMARY Specificity of Stationary Head CT for the Detection of a Fracture |
16 | 0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Medically stable patient with head trauma or known intracranial hemorrhage (subdural or intraparenchymal) or skull fractures
- Patient has undergone conventional head CT imaging at UNC hospitals within the past 24 hours or will undergo a CT scan of the head
- Willing and able to provide written informed consent
Exclusion Criteria
- Unable to provide consent
- Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses)
- Breastfeeding
Data sourced from ClinicalTrials.gov (NCT04495634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.