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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043621
Receipt No. R000049747
Scientific Title Effect of gravity on anatomical structures of the human body: evaluation using Upright CT
Date of disclosure of the study information 2021/03/16
Last modified on 2021/05/31

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Basic information
Public title Effect of gravity on anatomical structures of the human body: evaluation using Upright CT
Acronym Effect of gravity on anatomical structures of the human body
Scientific Title Effect of gravity on anatomical structures of the human body: evaluation using Upright CT
Scientific Title:Acronym Effect of gravity on anatomical structures of the human body
Region
Japan

Condition
Condition 1. Healthy volunteers
2. Patients who may have a different symptom or an anatomical structure between upright and supine positions
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Neurology
Infectious disease Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Breast surgery Obsterics and gynecology Ophthalmology
Orthopedics Urology Radiology
Neurosurgery Cardiovascular surgery Plastic surgery
Aesthetic surgery Rehabilitation medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare morphological features for various anatomical structures in healthy volunteers or patients who may have a different symptom or an anatomical structure between upright and supine positions using upright and conventional CT.
Basic objectives2 Others
Basic objectives -Others To explore the relationship between morphological parameters on CT images and clinical data.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Morphological parameters on images
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Conventional CT in the supine position
Interventions/Control_2 Upright CT in the standing and sitting positions
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 1. Healthy volunteers (age equal to or more than 20 years)
2. Patients who may have a different symptom or an anatomical structure between the upright and supine positions, and who are referred for conventional CT examination (age equal to or more than 20 years)
3. Subjects who provide written informed consent

Key exclusion criteria 1. Subjects who do not provide written informed consent
2. Known or possible pregnancy
3. Claustrophobia
4. Subjects who are not able to undergo CT examination
5. In case of using iodine contrast agent, subjects with a history of allergy of iodine contrast agent, with asthma, or with impaired renal function
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Jinzaki
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku,Tokyo, 160-8582, Japan
TEL 03-3353-1977(+81-3-3353-1977)
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name Yoshitake
Middle name
Last name Yamada
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku,Tokyo,160-8582, Japan
TEL 03-5363-3837(+81-3-5363-3837)
Homepage URL
Email yamada@rad.med.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Comittee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3503 (+81-3-5363-3503)
Email med-rinri-jimu@adst.keio.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

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 16 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
2021 Year 02 Month 24 Day
Date of IRB
2021 Year 03 Month 16 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2026 Year 03 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
2021 Year 03 Month 16 Day
Last modified on
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049747

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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