NCT01598766

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

May 11, 2012

Last Update Submit

February 4, 2013

Conditions

Multiple MRI Exams, IncludingCardiacAbdominalLumbarNeckPelvis

Outcome Measures

Primary Outcomes (1)

  • 16 Channel Flex Coil

    The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.

    May 2012-May 2013

Secondary Outcomes (1)

  • 8 Channel Value Breast Coil

    6 months

Study Arms (1)

Diagnostic Coil

EXPERIMENTAL

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

Device: 16 Channel SPEEDER Flex Coil

Interventions

16 Channel SPEEDER Flex CoilDEVICE

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

Diagnostic Coil

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Any contraindication to MRI procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steinberg Diagnostic Medical Imaging

Henderson, Nevada, 89052, United States

RECRUITING

Study Officials

  • Mark L Winkler, MD

    Steinberg Diagnostic Medical Imaging

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Kelly

CONTACT

7146046242ekelly@tams.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2012

First Posted

May 15, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2020

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)