UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002564 |
|---|---|
| Receipt number | R000003125 |
| Scientific Title | The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy |
| Date of disclosure of the study information | 2009/09/30 |
| Last modified on | 2011/04/01 02:45:33 |
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Basic information
Public title
The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Acronym
The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Scientific Title
The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Scientific Title:Acronym
The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Region
| Japan |
Condition
Condition
The patients with established Crohn's disease and the other established or suspected small bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of new Agile patency capsule for patients with established Crohn's disease and the other small bowel disease who undergo capsule endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of retention of capsule endoscope in patients confirmed patency with new Agile patency capsule
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Period: from 1st, September, 2009 to 31st, July, 2010
The number of examined patients: a total 50 cases/ 2 institutions (25 cases/ institution)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with established Crohn's disease and the other established or suspected small bowel disease
Key exclusion criteria
1: Patients with established retention or impaction of capsule endoscopy by the other examinations for small bowel
2: No bowel movements for over 4 days
3: Abdominal operated patients with difficulty to confirm safety to perform this investigation with the other examinations for small bowel
4: Subjects with pacemakers or other implanted electromedical devices
5: Swallowing disorder
6: Pregnant women
7: Patients with difficulty to perform the prescribed examinations
8: A serious patient
9: Participating or planned patient to the other clinical trials
10: The patient who the physician judged as inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Watanabe, M.D., Ph.D. |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Gastroenterology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-3811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Watanabe, M.D., Ph.D. |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Gastroenterology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-3811
Homepage URL
kenjiw@med.osaka-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka City University, Department of Gastroenterology
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
大阪市立大学医学部付属病院（大阪府）、名古屋大学医学部付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 30 | Day |
Last modified on
| 2011 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003125
