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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030251
Receipt No. 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 2019/12/06

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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
Email 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
Email miyatake.orj@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034549

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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