UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022812 |
|---|---|
| Receipt number | R000026291 |
| Scientific Title | Efficient surveillance of small bowel lesions in Crohn's disease |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2017/12/21 10:08:52 |
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Basic information
Public title
Efficient surveillance of small bowel lesions in Crohn's disease
Acronym
Efficient surveillance of small bowel lesions in Crohn's disease
Scientific Title
Efficient surveillance of small bowel lesions in Crohn's disease
Scientific Title:Acronym
Efficient surveillance of small bowel lesions in Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficient surveillance of the small bowel lesions in Crohn's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of small bowel lesions in Crohn's disease by using capsule endoscopy
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Crohn's disease patients without intestinal stricture
(2) Patients underwent per-anal balloon-assisted enteroscopy and the entire small intestine could not be observed
Key exclusion criteria
(1) Existing history or results of examination suggesting intestinal stricture
(2) Anal stricture
(3) Pregnant woman
(4) Patients with pacemaker or ICD
(5) Patients with swallowing disturbance
(6) Patients with a history of hypersensitivity to barium sulfate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Andoh |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 20 | 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
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026291
