General Investigative MRI Protocol

NCT ID: NCT01598766

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-05-31

Brief Summary

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This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.

Detailed Description

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Conditions

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Multiple MRI Exams, Including Cardiac Abdominal Lumbar Neck Pelvis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic Coil

This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams

Group Type EXPERIMENTAL

16 Channel SPEEDER Flex Coil

Intervention Type DEVICE

This is a 16 element MRI coil, flexible, lightweight. Multiple uses.

Interventions

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16 Channel SPEEDER Flex Coil

This is a 16 element MRI coil, flexible, lightweight. Multiple uses.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.

Exclusion Criteria

* Any contraindication to MRI procedures
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toshiba America Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark L Winkler, MD

Role: PRINCIPAL_INVESTIGATOR

Steinberg Diagnostic Medical Imaging

Locations

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Steinberg Diagnostic Medical Imaging

Henderson, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Kelly

Role: CONTACT

7146046242

Facility Contacts

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Erin Kelly, PhD

Role: primary

714-604-6242

Other Identifiers

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05069

Identifier Type: -

Identifier Source: org_study_id

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