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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030386
Receipt No. R000034687
Scientific Title Feasibility study on the clinical usefulness of upright CT for surgical diseases
Date of disclosure of the study information 2017/12/13
Last modified on 2018/12/14

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Basic information
Public title Feasibility study on the clinical usefulness of upright CT for surgical diseases
Acronym Feasibility study on the clinical usefulness of upright CT for surgical diseases
Scientific Title Feasibility study on the clinical usefulness of upright CT for surgical diseases
Scientific Title:Acronym Feasibility study on the clinical usefulness of upright CT for surgical diseases
Region
Japan

Condition
Condition Surgical diseases
Classification by specialty
Surgery in general Vascular surgery Breast surgery
Obsterics and gynecology Urology Radiology
Plastic surgery Aesthetic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare morphological features in patients with surgical diseases among standing, sitting, and supine positions using upright and conventional CT.
To explore the relationship between morphological parameters on CT images and clinical data.
Basic objectives2 Others
Basic objectives -Others To evaluate the clinical usefulness of upright CT in a standing or sitting position.
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 Upright 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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects who are referred for CT exmamination for the assessment of known or possible surgical diseases (breast disease, abdominal hernia, pelvic organ prolapse or vascular disease)
2. Age equal to or more than 20 years
3. Subjects who provide written informed consent
Key exclusion criteria 1. Known or possible pregnancy
2. Subjects who are not able to undergo CT examination in a standing or sitting position
3. Subjects who do not provide written informed consent
Target sample size 200

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 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)
Homepage URL
Email jinzaki@rad.med.keio.ac.jp

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

Funding Source
Organization Canon Medical Systems Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 13 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 09 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 23 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 12 Month 13 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034687

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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