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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028743
Receipt No. R000032893
Scientific Title Evaluation of diagnostic ability for intestinal ischemia in small bowel obstruction by MRI
Date of disclosure of the study information 2017/12/01
Last modified on 2019/08/21

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Basic information
Public title Evaluation of diagnostic ability for intestinal ischemia in small bowel obstruction by MRI
Acronym Evaluation of diagnostic ability for intestinal ischemia in small bowel obstruction by MRI
Scientific Title Evaluation of diagnostic ability for intestinal ischemia in small bowel obstruction by MRI
Scientific Title:Acronym Evaluation of diagnostic ability for intestinal ischemia in small bowel obstruction by MRI
Region
Japan

Condition
Condition small bowel obstruction
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of diagnostic ability for intestinal ischemia in small bowel obstruction by MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes accuracy rate of strangulated small bowel obstruction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Examination of an MRI scan
Interventions/Control_2
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
120 years-old >=
Gender Male and Female
Key inclusion criteria The patients who has a diagnosis of small bowel obstruction
The patients who can hold one's breath in supine position
The patients who can agree by the document
Key exclusion criteria pregnant woman
The person who is participating in other studies
The person that MRI cannot be performed because of pacemaker and tattoo
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shigetaka
Middle name
Last name Sato
Organization Shiga University of Medical Science
Division name Department of radiology
Zip code 5202192
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2288
Email kanimiso@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Shigetaka
Middle name
Last name Sato
Organization Shiga University of Medical Science
Division name Department of radiology
Zip code 5202192
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2288
Homepage URL
Email kanimiso@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical 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 Shiga University of Medical Science
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel 077-548-3576
Email hqrec@belle.shiga-med.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
2017 Year 12 Month 01 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 08 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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 19 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032893

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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