An Evaluation of Near-Infrared Spectroscopy for Intracran... | NCT02222597

Studies
An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.

NCT02222597

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 26, 2014Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Within 12 Hrs of Head Injury

Interventions

infrascanner

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Aug 20, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2014

Last Update Posted Date

Aug 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Label	Type	Description	Intervention Names
positive infrascanner finding			Device: infrascanner

Name	Type	Description	Arm Group Labels	Other Names
infrascanner	Device		positive infrascanner finding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detect the predictive value of the infrascanner for intracranial hemorrhage		within 12 hours after head injury

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.

Exclusion Criteria:

The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.
Patients with massive scalp laceration or hematoma were excluded. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients within 12 hours after head injury visit the Emergency Department of the NTUH.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meng-Che Wu, MD	Contact	+886-972653208		mengcher111@gmail.com
Cheng-Yi Wu, MD	Contact	+886-972653218		alanwuem@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital Emergency Department	Recruiting	Taipei	Taiwan		Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma
D020300	Intracranial Hemorrhages

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided