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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043687
Receipt No. R000049886
Scientific Title Learning curve of intestinal ultrasound in inflammatory bowel disease
Date of disclosure of the study information 2021/03/23
Last modified on 2021/03/21

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Basic information
Public title Learning curve of intestinal ultrasound in inflammatory bowel disease
Acronym Learning curve of intestinal ultrasound in IBD
Scientific Title Learning curve of intestinal ultrasound in inflammatory bowel disease
Scientific Title:Acronym Learning curve of intestinal ultrasound in IBD
Region
Japan

Condition
Condition Inflammatory bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the number of experienced cases required to acquire the intestinal ultrasound procedure
Basic objectives2 Others
Basic objectives -Others Examination of match rate between instructors
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Examining the concordance rate of test results conducted by instructors and trainees
Key secondary outcomes Examining the concordance rate of the test results conducted by the two instructors

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1.Patients who gave written and oral explanations and obtained written consent to participate in the study
2.Patients over 15 years old, regardless of gender
3.Patients with a definitive diagnosis of IBD
Key exclusion criteria 1.Patients after total colectomy
2.When the doctor determines that the study is not medically and ethically appropriate
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Aya
Middle name
Last name Hojo
Organization Kitasato University Kitasato Institute Hospital
Division name Center for Advanced IBD Research and Treatment
Zip code 108-8642
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 0334446161
Email aya.hojo.828@gmail.com

Public contact
Name of contact person
1st name Aya
Middle name
Last name Hojo
Organization Kitasato University Kitasato Institute Hospital
Division name Center for Advanced IBD Research and Treatment
Zip code 108-8642
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 0334446161
Homepage URL
Email aya.hojo.828@gmail.com

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization Kitasato University Kitasato Institute Hospital
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 Kitasato University Kitasato Institute Hospital
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel 0334446161
Email aya.hojo.828@gmail.com

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
2021 Year 03 Month 23 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
2020 Year 12 Month 12 Day
Date of IRB
2021 Year 01 Month 05 Day
Anticipated trial start date
2021 Year 03 Month 02 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruitment of subjects: IBD patients undergoing intestinal ultrasound examination at our hospital between March 2, 2021 and March 31, 2022

Management information
Registered date
2021 Year 03 Month 21 Day
Last modified on
2021 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049886

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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