UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005107 |
|---|---|
| Receipt number | 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 13:36:13 |
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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
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
Sponsor or person
Institute
Center for Diagnostic and Therapeutic Endoscopy, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006072
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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