UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043687 |
|---|---|
| Receipt number | 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 | 2024/03/23 09:30:08 |
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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
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
aya.hojo.828@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
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
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049886
