Trial document





This trial has been registered retrospectively.
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  DRKS00003556

Trial Description

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Title

Optimisation of Image Quality, Image Resolution and Acquisition Speed
With an Innovative MRI System

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is set up to evaluate the image quality, acquisition speed and image resolution of a new MR device in 250 patients.

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Brief Summary in Scientific Language

one arm, open label device study to evaluate performance of an innovative MR-device

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Organizational Data

  •   DRKS00003556
  •   2012/03/05
  •   [---]*
  •   no
  •   Approved
  •   FF 107/2011, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  •   CIV-11-10-002822 
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Health Condition or Problem studied

  •   Patients with clinical indications for a MRI exam.
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Interventions/Observational Groups

  •   MRI examination (no contrast agent)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary objective is to evaluate and further optimize image quality, image resolution and
acquisition speed of an innovative MRI system

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Secondary Outcome

The secondary objectives are to evaluate clinical workflow, system handling and patient
comfort. These will be evaluated by the investigators for every examination, using a visual analog scale.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/12/06
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with a clinical indication for an MRT examination
Patients, who have been adequately informed and have given their written informed consent
for participation in the clinical investigation

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Exclusion Criteria

Patients who are participating in another study that requires Ethics Committee approval.
Non-interventional studies are permitted.
Patients with one or more of the following:
o Claustrophobia
o Cardiac arrhythmia
o Cardiac pacemaker
o Intrauterine device
o Pregnant female patients, and female patients with suspicion of
pregnancy
o Metal or metal implant in patient´s body
o Persons with spasm or seizure disorder
o Persons, who are either not adult, not sui juris, or who are
institutionalized by court order.

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Addresses

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    • Siemens AG
    • Mr.  Dr.  Richard  Winkelmann 
    • Allee am Roethelheimpark
    • 91052  Erlangen
    • Germany
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    • Siemens AG
    • Ms.  Dr. med.  Eva-Maria  Rueth 
    • Henkestr. 127
    • 91052  Erlangen
    • Germany
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  • start of 1:1-Block address public-contact
    • Siemens AG
    • Ms.  Dr. med.  Eva-Maria  Rueth 
    • Henkestr. 127
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Siemens AG
    • Allee am Roethelheimpark
    • 91052  Erlangen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/23
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.