UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023163 |
|---|---|
| Receipt number | R000026442 |
| Scientific Title | Development of MR Systems, Components, and Accessories |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2017/12/18 11:28:41 |
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Basic information
Public title
Development of MR Systems, Components, and Accessories
Acronym
Development of MR Systems, Components, and Accessories
Scientific Title
Development of MR Systems, Components, and Accessories
Scientific Title:Acronym
Development of MR Systems, Components, and Accessories
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of MR Systems, Components, and Accessories
Basic objectives2
Others
Basic objectives -Others
(1) Perform iterative evaluations of the device and new feature as feasibility
(2) Perform activities in support of design validation, verification
(3) Evaluate device complaints and analyze potential causes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of MR Systems, Components, and Accessories
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Scan with MRI system. up to 2 scans in the MRI that will each last 60 minutes or less. Subject may not attend more than 2 study visits during any one calendar week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult
Key exclusion criteria
Screening for MRI scanning Failure
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokiko Sodani |
Organization
GE Healthcare Japan
Division name
MR Engineering
Zip code
Address
4-7-127, Asahigaoka, Hino-shi, Tokyo
TEL
042-585-3864
tokiko.sodani@ge.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Matsumoto |
Organization
GE Healthcare Japan
Division name
MR Engineering
Zip code
Address
4-7-127, Asahigaoka, Hino-shi, Tokyo
TEL
042-514-3700
Homepage URL
HINOMRCLSTUDY.Admin@ge.com
Sponsor or person
Institute
GE Healthcare
Institute
Department
Personal name
Funding Source
Organization
GE Healthcare Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
20160990
Org. issuing International ID_1
WIRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Reason:
Study Closure as early termination.
Effectiveness:
As the result of NPI or production engineering standpoint, we could accomplish Signa Pioneer phase 2 production release through this clinical study protocol.
Safety:
Adverse Event: Zero case reported
Incidental Finding: 18 findings,notified to the each subject
Device Complaints: 1complaints.
Closed by installing resolved SW version.
Deviation: Zero case reported
Status of Protocol implementation:
Recruitment/Enrollment:
From 15-Jul-2016, to the latest enrollment 29-Aug-2017, 46 subjects enrolled through the recruitment by Poster/E-mail, etc.
Scan Procedure:
A total of 46 subjects provided consent and were screened for participation in this study.
The scan purpose of this study is 91% for Signa Pioneer phase 2 development, 3% for IB(Signa Pioneer) and 6% for other development on Pioneer (3.0T MRI scanner). A total of 795 MR scan sessions were completed across the 46 enrolled subjects(45 subjects at the timing of closure)
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 07 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 07 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 07 | Day |
Other
Other related information
Signa Pioneer commercial production release
Management information
Registered date
| 2016 | Year | 07 | Month | 14 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026442
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
