UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research of the usefulness of CT in a standing or sitting position for functional gastrointestinal disorders
Acronym	Feasibility of CT in a standing or sitting position for functional gastrointestinal disorders
Scientific Title	Exploratory research of the usefulness of CT in a standing or sitting position for functional gastrointestinal disorders
Scientific Title:Acronym	Feasibility of CT in a standing or sitting position for functional gastrointestinal disorders
Region	Japan

Condition
Condition	Functional gastrointestinal disorders
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare gastrointestinal morphological features and motion in patients with among standing, sitting, and supine positions using horizontal and conventional CT. To explore the relationship between gastrointestinal morphological parameters on CT images and clinical data.
Basic objectives2	Others
Basic objectives -Others	To evaluate the clinical usefulness of horizontal 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	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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects who are referred for CT for assessment of known or possible functional gastrointestinal disorders 2. Age equal to or more than 20 years 3. Consent has been obtained by the document of cooperation to this study from the subject
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	150

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

Public contact
Name of contact person	1st name Tatsuhiro Middle name Last name Masaoka
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	03-5363-3790(+81-3-5363-3790)
Homepage URL
Email	masaoka@keio.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

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee)
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel	03-5363-3503
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	2018 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	22
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	2018 Year 04 Month 25 Day
Date of IRB	2018 Year 04 Month 26 Day
Anticipated trial start date	2018 Year 04 Month 27 Day
Last follow-up date	2021 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	2018 Year 04 Month 25 Day
Last modified on	2021 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036926