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Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

E

East Limburg Hospital

Status

Completed

Conditions

Head Trauma
Brain Surgery
Ischemic Stroke
Intracranial Hemorrhage
Brain Tumor
Headache

Treatments

Device: Infrascanner

Study type

Interventional

Funder types

Other

Identifiers

NCT02809651
16/015U

Details and patient eligibility

About

The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.

Full description

Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).

Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.

Enrollment

89 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with ischemic stroke diagnosed by clinical examination and CT-scan
  • Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI
  • Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan
  • Patients that have undergone brain surgery
  • Patients with a normal CT-scan of the brain after head trauma
  • Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up

Exclusion criteria

  • none

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

89 participants in 6 patient groups

Ischemic stroke
Experimental group
Description:
patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan
Treatment:
Device: Infrascanner
Brain tumor
Experimental group
Description:
patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI
Treatment:
Device: Infrascanner
Brain surgery
Experimental group
Description:
patients that have undergone brain surgery
Treatment:
Device: Infrascanner
Intracranial hemorrhage
Active Comparator group
Description:
patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan
Treatment:
Device: Infrascanner
Headache
Experimental group
Description:
patients with headache complaints and a normal CT-scan of the brain
Treatment:
Device: Infrascanner
Headtrauma
Experimental group
Description:
patients with head trauma and a normal CT-scan of the brain
Treatment:
Device: Infrascanner

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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