Pediatric Radio Frequency Coils Generic
This study is currently recruiting participants.
Verified May 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01633866
First received: June 21, 2012
Last updated: May 7, 2013
Last verified: May 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 21, 2012 | ||||
| Last Updated Date | May 7, 2013 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of participants with adverse events as measured by heating and comfort participant response [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01633866 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
MRI Image Quality [ Time Frame: 2 Weeks Post MRI Scan ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pediatric Radio Frequency Coils Generic | ||||
| Official Title ICMJE | Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners | ||||
| Brief Summary | The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC). |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Device: RF Coils
RF coil scanning of effectiveness and safety in healthy participants and clinical patients. |
||||
| Study Arm (s) | Experimental: Advances in Radio Frequency for MRI
advances in radio frequency (RF) coil magnetic resonance imaging (MRI)
Intervention: Device: RF Coils |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy participants:
Clinical patients:
Exclusion Criteria: Healthy participants & Clinical patients
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01633866 | ||||
| Other Study ID Numbers ICMJE | 2012-1041 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||
| Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||
| Verification Date | May 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||