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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023163
Receipt No. 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

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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
Email 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
Email HINOMRCLSTUDY.Admin@ge.com

Sponsor
Institute GE Healthcare
Institute
Department

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
Email

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
URL(English) https://upload.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


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