Philips Magnetic Resonance Study – Human Volunteer Scanning for System Pre-Development
- Conditions
- The objective of this study is to generate MR system data, including camera and sensor accessory data, on adults to assess the potential of new MR research approaches for potentially improving the technical performance of the MRI system. The study is not intended to make medical claims or provide diagnostic evidence.
- Registration Number
- DRKS00031712
- Lead Sponsor
- Philips GmbH Innovative Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 4000
•Participants willing and capable of providing informed consent and physically capable of performing study related activities (i.e., lying still in a MR scanner)
• Participant is at least 18 years old and not older than 75 years
•Participant with medical history (anamnesis) of severe hypertension, diabetes, cardiovascular and cerebrovascular diseases, COPD (chronic obstructive pulmonary disease) and other severe acute or chronic diseases (e.g., Cancer)
•Participants with history of severe congenital diseases such as congenital heart disease.
•Participant with epilepsy
•Participant with any type of electronic, mechanical, or magnetic implant (Examples: insulin pump, pacemaker, defibrillator, neurostimulator, cochlear implant)
•Participant with small metal components in the body (vascular clips, metal splinters, stents, filters or catheters)
•Participants with contraceptive coils, dental braces etc. which are not MR conditional or MR safe
•Participant with dermal medicinal patches
•Participant with any piercings and/or any tattoos and/or permanent make-up
•Participant with Meniere’s disease or Vertigo
•Claustrophobia, anxiety disorder or panic attacks
•Female participant who reports to be pregnant or believes she could be pregnant
•Eye or other injuries by metal splinters
•Any known contraindications for MR scanning
•Unless cleared by a physician:
oMetal implants such as surgical implants, prostheses, IUDs
oTattoos or permanent make-up
oOther disease or condition or incidental findings
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to generate MR system data, including camera and sensor accessory data, on adults to assess the potential of new MR research approaches for potentially improving the technical performance of the MRI system. Furthermore, the data will be used to evaluate user preference evaluations, and/or to demonstrate the capabilities of MR equipment for educational purposes. The data (e.g., imaging data) and feedback obtained during the study will be used for pre-development, image optimization, research, troubleshooting, demonstration, and training in the domain of medical imaging.
- Secondary Outcome Measures
Name Time Method Furthermore, (image) optimization, troubleshooting and demonstration of potential Philips MR devices, including aspects of educating of research personnel are in the focus.