NCT02809651

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

June 18, 2016

Last Update Submit

March 13, 2017

Conditions

Ischemic StrokeBrain TumorBrain SurgeryIntracranial HemorrhageHeadacheHead Trauma

Keywords

InfrascannerIntracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)

    5 minutes

Study Arms (6)

Ischemic stroke

EXPERIMENTAL

patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan

Device: Infrascanner

Brain tumor

EXPERIMENTAL

patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI

Device: Infrascanner

Brain surgery

EXPERIMENTAL

patients that have undergone brain surgery

Device: Infrascanner

Intracranial hemorrhage

ACTIVE COMPARATOR

patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan

Device: Infrascanner

Headache

EXPERIMENTAL

patients with headache complaints and a normal CT-scan of the brain

Device: Infrascanner

Headtrauma

EXPERIMENTAL

patients with head trauma and a normal CT-scan of the brain

Device: Infrascanner

Interventions

InfrascannerDEVICE

bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.

Brain surgeryBrain tumorHeadacheHeadtraumaIntracranial hemorrhageIschemic stroke

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Ischemic StrokeBrain NeoplasmsIntracranial HemorrhagesHeadacheCraniocerebral Trauma

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Pascal Vanelderen, MD, PhD

    member of Staff

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 18, 2016

First Posted

June 22, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)