Trial record 1 of 5 for:    toshiba [Lead]
Previous Study | Return to List | Next Study

General Investigative MRI Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Toshiba America Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01598766
First received: May 11, 2012
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Multiple MRI Exams, Including
Cardiac
Abdominal
Lumbar
Neck
Pelvis
Device: 16 Channel SPEEDER Flex Coil
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T

Further study details as provided by Toshiba America Medical Systems, Inc.:

Primary Outcome Measures:
  • 16 Channel Flex Coil [ Time Frame: May 2012-May 2013 ] [ Designated as safety issue: No ]
    The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.


Secondary Outcome Measures:
  • 8 Channel Value Breast Coil [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    clinical evaluation to determine if an 8 channel mri breast coil meets industry standards.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic Coil
This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams
Device: 16 Channel SPEEDER Flex Coil
This is a 16 element MRI coil, flexible, lightweight. Multiple uses.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598766

Contacts
Contact: Erin Kelly 7146046242 ekelly@tams.com

Locations
United States, Nevada
Steinberg Diagnostic Medical Imaging Recruiting
Henderson, Nevada, United States, 89052
Contact: Erin Kelly, PhD    714-604-6242    ekelly@tams.com   
Principal Investigator: Mark L Winkler, MD         
Sponsors and Collaborators
Toshiba America Medical Systems, Inc.
Investigators
Principal Investigator: Mark L Winkler, MD Steinberg Diagnostic Medical Imaging
  More Information

No publications provided

Responsible Party: Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01598766     History of Changes
Other Study ID Numbers: 05069
Study First Received: May 11, 2012
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014