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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028565
Receipt No. 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 2018/02/24

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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
Middle name
Last name Masahiro Jinzaki
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code
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
Middle name
Last name Yoshiaki Sakamoto
Organization Keio University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3814(+81-3-5363-3814)
Homepage URL
Email ysakamoto@z8.keio.jp

Sponsor
Institute Department of Radiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
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
2018 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031600

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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