Recruiting
Phase 1

Observational Study

Sponsor:

Toshiba America Medical Systems, Inc.

Code:

NCT01598766

Conditions

Multiple MRI Exams, Including

Cardiac

Abdominal

Lumbar

Neck

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

16 Channel SPEEDER Flex Coil

Study Details

Brief summary:

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.

Conditions

Multiple MRI Exams, Including

Cardiac

Abdominal

Lumbar

Neck

Study ID

NCT01598766

Start date

May, 2012

Status verified date

Feb, 2013

Completion date

May, 2020

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic Coil

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

Interventions

16 Channel SPEEDER Flex Coil

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

Primary outcome measure

  • 16 Channel Flex Coil [ Time Frame: May 2012-May 2013 ]

Central Contacts and Locations

Central contacts

Erin Kelly

7146046242ekelly@tams.com

Locations

Steinberg Diagnostic Medical Imaging

Recruiting

Henderson, Nevada, United States, 89052

Contacts

Erin Kelly, PhD

714-604-6242ekelly@tams.com

Principal Investigator:

Mark L Winkler, MD

More Information

Sponsor

Toshiba America Medical Systems, Inc.

Last update posted

Feb 5, 2013

Last verified

Feb, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toshiba America Medical Systems, Inc. on 2013-02-05.