UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028565 |
|---|---|
| Receipt number | R000031600 |
| Scientific Title | The comparison of structures for the diseases in plastic and reconstructive surgery using CT in a standing and spine position -pilot study- |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2019/08/08 09:29:36 |
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Basic information
Public title
The comparison of structures for the diseases in plastic and reconstructive surgery using CT in a standing and spine position -pilot study-
Acronym
The comparison of structures for the diseases in plastic and reconstructive surgery using CT in a standing and spine position
Scientific Title
The comparison of structures for the diseases in plastic and reconstructive surgery using CT in a standing and spine position -pilot study-
Scientific Title:Acronym
The comparison of structures for the diseases in plastic and reconstructive surgery using CT in a standing and spine position
Region
| Japan |
Condition
Condition
The diseases in plastic and reconstructive surgery
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate values on CT images between standing, and supine positions for lesion in plastic and reconstructive surgery.
Basic objectives2
Others
Basic objectives -Others
To investigate values between affected and unaffected sides in standing and supine positions.
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 a supine position
Interventions/Control_2
Horizontal CT in a 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The patients aged over 20 years old,
2. The patients who are going to perform the operation in plastic and reconstructive surgery, and preoperative CT is necessary to prepare the operation.
3. Subjects who understand the purpose of this study and provide written informed consent.
Key exclusion criteria
1. Known or possible pregnancy
2. Subjects who are not able to undergo CT in a standing or sitting position
3. Subjects who do not provide written informed consent
Target sample size
100
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
1608582
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 | Yoshiaki |
| Middle name | |
| Last name | Sakamoto |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3814(+81-3-5363-3814)
Homepage URL
ysakamoto@z8.keio.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Canon medical systems
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
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
0333531211
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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 10 | 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
2
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 08 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031600
| 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 |
