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Procedure
MRI Development Study
Verified Trial
N/A
Recruiting
Led By Rob Fraser, MD
Research Sponsored by GE HealthCare Technologies Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are you able to walk 350 feet and climb two steps without assistive devices?
Are you able to hear and understand English without an assistive device?
Must not have
Do you have any type of metal implant, prosthetic, implanted pacemaker or defibrillator, or previous injury involving a metallic object?
Do you have 1 or more tattoos?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during mri scan
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to test and potentially improve MRI devices.
Who is the study for?
This clinical trial is open to individuals who are eligible for MRI scans. Specific eligibility criteria are not provided, but typically participants should not have any contraindications to MRI such as certain metal implants, claustrophobia without sedation options, or severe medical conditions affecting the ability to lie still.
What is being tested?
The study is focused on evaluating the performance of an MRI system along with its components and accessories. Participants will undergo scan sessions aimed at collecting data that helps in assessing the development of these systems.
What are the potential side effects?
MRI does not involve radiation and side effects are rare. However, some may experience discomfort from lying still, loud noises during scanning, or feelings of claustrophobia. In very few cases, allergic reactions to contrast agents used in some MRI scans can occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during mri scan.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during mri scan.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The number and description of unexpected device complaints/deficiencies that occur outside of expected and controlled engineering optimization.
The number and type of safety issues, including AEs and SAEs.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: the studyExperimental Treatment1 Intervention
Patients with a PPM or ICD getting a clinically indicated MRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810
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Who is running the clinical trial?
GE HealthCare Technologies IncLead Sponsor
Rob Fraser, MDPrincipal InvestigatorGE HealthCare Technologies Inc
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