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Stationary Head CT for Head Trauma

N/A

Waitlist Available

Led By Deanna Sasaki-Adams, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Medically stable patient with head trauma or known intracranial hemorrhage (subdural or intraparenchymal) or skull fractures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upon completion of all study image data collection for all participants [approximately 1 year]

Awards & highlights

Study Summary

This trial will test whether a new type of CT scan, called stationary head CT (s-HCT), is a better diagnostic tool for head trauma than the conventional CT scan. 50 people who have had a head trauma or brain bleed in the past 24 hours will have the new scan, and the results will be compared to those of a conventional CT scan.

Who is the study for?

This trial is for adults over 18 who have experienced head trauma or a brain bleed, are medically stable, and can give written consent. They must have had a conventional head CT scan at UNC hospitals within the last day or be scheduled to get one.Check my eligibility

What is being tested?

The study is testing a new type of stationary head CT (s-HCT) as a diagnostic tool for patients with traumatic brain injuries. It's a single-visit study without follow-up where images from s-HCT will be compared to those from regular CT scans by physician readers.See study design

What are the potential side effects?

Since this trial involves imaging similar to standard CT scans, potential side effects may include exposure to low levels of radiation which carries a small risk of cancer over the long term.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a stable condition after a head injury or brain bleed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upon completion of all study image data collection for all participants [approximately 1 year]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upon completion of all study image data collection for all participants [approximately 1 year]

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of all study image data collection for all participants [approximately 1 year] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity of Stationary Head CT for the Detection of a Hemorrhage

Secondary outcome measures

Sensitivity of Stationary Head CT for the Detection of a Fracture

Specificity of Stationary Head CT for the Detection of a Fracture

Specificity of Stationary Head CT for the Detection of a Hemorrhage

Trial Design

1Treatment groups

Experimental Treatment

Group I: Head Trauma or Brain BleedExperimental Treatment1 Intervention

Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stationary Head CT (s-HCT)

2022

N/A

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,191,025 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,682 Total Patients Enrolled

Deanna Sasaki-Adams, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor currently grant admittance to participants?

"This clinical trial is currently searching for participants, as indicated on the website. The study was initiated on October 12th 2022 and its information was most recently updated November 2nd 2022."

Answered by AI

How many participants are actively partaking in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical research project is currently recruiting volunteers for enrollment; the trial was launched on October 12th 2022 and has been updated as of November 2nd 2022. The investigation requires 50 participants from a singular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

2022. "Evaluation of a Carbon Nanotube Enabled Solid-State Head CT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04495634.