Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04666766
Eligibility Criteria:
Inclusion Criteria (groups A and B):
* Verbal Informed Consent in the acute phase.
* Signed Informed Consent Form after the acute phase. On behalf of the patient, independent witness signed informed consent (in cases where the patient is unable to sign).
* Acute trauma patient with suspected head injury
* Time from injury to measurement procedure not longer than 8 hours 15 min
* Head CT prescribed by treating physician
* Patient is ≥ 18 years of age
* Patient is deemed clinically stable
Exclusion Criteria (groups A and B):
* Patient has suspected cervical spine fracture, per the Investigator's judgement
* Patient has by CT confirmed cervical spine fracture
* Patient has confirmed skull fracture with risk for dislocation.
* Patient has a shunt or other foreign object implanted intracranially (if known by medical records)
* Patient has agraffes or other metal parts, thick bandage (\>1cm), or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
* Patient diagnosed with a condition associated with risk of poor protocol compliance
* The measurement procedure is deemed to interfere with the standard of care
* Other condition or symptoms preventing the patient from entering the trial, per the investigator´s judgment
Inclusion Criteria (Group C):
* Patient is ≥ 18 years of age
* Signed informed consent
Exclusion Criteria (Group C):
• Previous stroke or other diagnosed and/or treated brain injury
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04666766
Study Brief:
Protocol Section:
NCT04666766