UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043621 |
|---|---|
| Receipt number | 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 10:20:56 |
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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 | Obstetrics 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)
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
yamada@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049747
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
