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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005107
Receipt No. R000006072
Scientific Title Evaluation of degree of severity in patients with ulcerative colitis by using colon capsule endoscope
Date of disclosure of the study information 2011/02/18
Last modified on 2015/12/03

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Basic information
Public title Evaluation of degree of severity in patients with ulcerative colitis by using colon capsule endoscope
Acronym Evaluation of degree of severity in patients with ulcerative colitis by using colon capsule endoscope
Scientific Title Evaluation of degree of severity in patients with ulcerative colitis by using colon capsule endoscope
Scientific Title:Acronym Evaluation of degree of severity in patients with ulcerative colitis by using colon capsule endoscope
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the degree of severity and the extent of the inflammatory lesions in patients with ulcerative colitis by using Colon Capsule Endoscope
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Completion rate of Colon Capsule endoscopy
Key secondary outcomes 1.Efficacy of the purgative and prokinetics
2.Frequency of adverse event
3.Comparison with conventional endoscopy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Performing conventional Colonoscopy after Colon Capsule 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. UC patient with mild activity.
2. UC patient with moderate activity.
3. UC patient in remission.
Key exclusion criteria 1) Ppatients with dysphagia.
2) Pregnant female.
3) Patient with pacemaker or other medical electronic equipment.
4) Patients who have history of the ileus or stricture or fistula of the intestine.
5) Patients who have history of radiation therapy.
6) Diagnosed or suspected Crohn's disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University
Division name Division of Gastroenterology, Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Center for Diagnostic and Therapeutic Endoscopy, Keio University
Institute
Department

Funding Source
Organization Division of Gastroenterology, Keio University.
Capsule provider is Given Imaging Ltd.
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
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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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
2011 Year 02 Month 18 Day
Last modified on
2015 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006072

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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