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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044292
Receipt No. R000050594
Scientific Title The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Date of disclosure of the study information 2021/07/01
Last modified on 2021/05/22

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Basic information
Public title The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Acronym The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Scientific Title The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Scientific Title:Acronym The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of colon capsule endoscopy as a next-generation screening test for mucosal healing of ulcerative colitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the diagnostic ability of colon capsule endoscopy using the mucosal healing / activity scale for ulcerative colitis.
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 Colon capsule endoscopy in patients with ulcerative colitis
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients aged 18 to 80
2) Those who can fully understand this clinical study and obtain consent
Key exclusion criteria 1) Dysphagia
2) Equipped with a pacemaker
3) Women who are pregnant or may become pregnant
4) Intestinal stenosis (small intestine / large intestine)
5) Allergies to various laxatives
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoriaki
Middle name
Last name Komeda
Organization Kindai University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohnohigashi, Osaka-Sayama City, Osaka 589-8511, Japan
TEL 072-366-0221
Email y-komme@mvb.biglobe.ne.jp

Public contact
Name of contact person
1st name Sho
Middle name
Last name Masaki
Organization Kindai University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohnohigashi, Osaka-Sayama City, Osaka 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email sho1110sho1110@yahoo.co.jp

Sponsor
Institute Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization none
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 Kindai University Faculty of Medicine
Address 377-2 Ohnohigashi, Osaka-Sayama City, Osaka 589-8511, Japan
Tel 072-366-0221
Email y-komme@mvb.biglobe.ne.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
2021 Year 07 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2026 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 22 Day
Last modified on
2021 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050594

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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