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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003879
Receipt No. R000004670
Scientific Title The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Date of disclosure of the study information 2010/07/06
Last modified on 2010/07/06

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Basic information
Public title The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Acronym The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Scientific Title The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Scientific Title:Acronym The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the diagnostic performance of MR enterocolonography by comparing results of this procedure to those of endoscopies for evaluating the small and large bowel lesions of patients with Crohn's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcomes is to evaluate sensitivity and specificity of MR Enterocolonography comparing to endoscopic mucosal lesions and stenosis.
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 Ileocolonoscopy or Double-balloon endoscopy
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients had been diagnosed with crohn's disease
Key exclusion criteria patients complicated for endoscopy (i.e. perforation)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Nagahori
Organization School of Medicine, Tokyo Medical and Dental University
Division name Gastroenterology and Hepatology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Tokyo Medical and Dental University
Division name Gastroenterology and Hepatology
Zip code
Address
TEL 03-5803-5877
Homepage URL
Email

Sponsor
Institute School of Medicine, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 06 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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 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
2010 Year 07 Month 06 Day
Last modified on
2010 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004670

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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