UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030251 |
|---|---|
| Receipt number | R000034549 |
| Scientific Title | Magnetic resonance imaging measurements of anatomical neurovascular structures by altering supine and lateral position. |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2020/12/07 13:38:37 |
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Basic information
Public title
Magnetic resonance imaging measurements of anatomical neurovascular structures by altering supine and lateral position.
Acronym
MRI measurements of neurovascular structures by positions.
Scientific Title
Magnetic resonance imaging measurements of anatomical neurovascular structures by altering supine and lateral position.
Scientific Title:Acronym
MRI measurements of neurovascular structures by positions.
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the anatomical neurovascular structures between positions in healthy volunteers.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiographic alteration of neurovascular structures by positions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
MRI performed in the supine position
Interventions/Control_2
MRI performed in the lateral position
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
Healthy volunteers without symptoms of hips
(staff or students of Tokyo Medical and Dental University or their family)
Key exclusion criteria
1) Patients who will not agree to this study.
2) Patients who have contraindications for MRI scan.
3)Past injuries or operations nearby hip joint.
4) Patients lacking ability of self-assessment due to dementia etc.
5) Minor patients.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Miyatake |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku
TEL
03-5803-5279
miyatake.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Miyatake |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
Homepage URL
miyatake.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachi,Ltd
Name of secondary funder(s)
Hitachi,Ltd
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Tokyo Medical and Dental University
Address
1-5-45 Yushima
Tel
03-5803-5279
syomu1.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都）
Tokyo Medical and Dental University Hospital of Medicine
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | 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
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
Suspended
Date of protocol fixation
| 2017 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034549
