Assessment of Siemens' GoBrain and DotBrain Software | NCT03269539

Studies
Assessment of Siemens' GoBrain and DotBrain Software

NCT03269539

Sponsor

University of Saskatchewan

Status

Unknown status

Last Update Posted

Aug 31, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Headache

Interventions

MRI Imaging

Countries

Not provided

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

May 2018Estimated

First Submitted Date

Aug 29, 2017

First Submission Date that Met QC Criteria

Aug 29, 2017

First Posted Date

Aug 31, 2017Actual

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 29, 2017

Last Update Posted Date

Aug 31, 2017Actual

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

Our main approach in this research is to collect MR data using both a "Routine" and "Fast" brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to determine if the "Fast" protocol can collect data in less time without compromising patient care.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Headache Patients		Patients Referred for MRI with History of Headaches	Other: MRI Imaging
Motion prone patients		Patients without the ability to remain still for the entire protocol	Other: MRI Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI Imaging	Other		Headache Patients Motion prone patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of Siemens' GoBrain and DotBrain Software		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients referred for MRI with History of Headaches

Exclusion Criteria:

Patient does not meet MRI safety criteria
Patient has known Brain Pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients referred for MRI with History of Headaches

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided