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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name