UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013802 |
|---|---|
| Receipt number | R000015978 |
| Scientific Title | The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis. |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2019/04/30 15:41:41 |
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Basic information
Public title
The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Acronym
The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Scientific Title
The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Scientific Title:Acronym
The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefluness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
We research relation between the passage time of Colon Capsule Endoscopy and the activity of Ulcerative colitis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of the mucosa in colon
Key secondary outcomes
passage time
Base
Study type
Others,meta-analysis etc
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients with active ulcerative colitis
Key exclusion criteria
1) The patients with a history of the operation of the bowels
2) Pregnant or breast feeding women and women suspected of being pregnant
3) The patients of the severe constipation
4) The patients with the history of the ileus
5) The patients who needs monitoring
6) The patients are severe or fulminant in
clinical activity of ulcerative colitis
7) The patients judged as inadequate for this study by attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
0282-87-2147
tfumi@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
0282-87-2147
Homepage URL
tfumi@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical 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
Dokkyo Medical University
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
Tel
0282-86-1111
tfumi@dokkyomed.ac.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
| 2014 | Year | 05 | 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
20
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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examination cancellation
Management information
Registered date
| 2014 | Year | 04 | Month | 24 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
