UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005856 |
|---|---|
| Receipt number | R000006918 |
| Scientific Title | Evaluation of small intestinal lesions in patients with ulcerative colitis by using capsule endoscopy |
| Date of disclosure of the study information | 2011/06/27 |
| Last modified on | 2011/06/27 16:59:38 |
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Basic information
Public title
Evaluation of small intestinal lesions in patients with ulcerative colitis by using capsule endoscopy
Acronym
Evaluation of small intestinal lesions in patients with ulcerative colitis by using capsule endoscopy
Scientific Title
Evaluation of small intestinal lesions in patients with ulcerative colitis by using capsule endoscopy
Scientific Title:Acronym
Evaluation of small intestinal lesions in patients with ulcerative colitis by using capsule endoscopy
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of small intestinal lesions in patients with ulcerative colitis, and investigation of relationship between small intestinal mucosal lesions and ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
To examine the relation between the existent of small intestinal lesions and the etiology of ulcerative colitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inquiry about the presence of small intestinal mucosal lesions, and pathological consideration in patients with ulcerative colitis.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis patients
Key exclusion criteria
1)Patients who have history of ileus or stricture or fistula of the intestine.
2)Diagnosed or suspected Crohn's disease.
3)Patients with pacemaker or other medical electronic equipment.
4)Patients with dysphagia.
5)Patients with uncontrolled heart failure.
6)Pregnant female.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Watanabe |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Gastroenterology and Hepatology, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the relation between the existent of small intestinal lesions and the etiology of ulcerative colitis.
Management information
Registered date
| 2011 | Year | 06 | Month | 27 | Day |
Last modified on
| 2011 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006918
