UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006320 |
|---|---|
| Receipt number | R000007492 |
| Scientific Title | A Cross-sectional study among Asymptomatic Long Term Low Dose Aspirin Users by using Video Capsule Endoscopy: |
| Date of disclosure of the study information | 2011/09/09 |
| Last modified on | 2013/03/30 15:11:11 |
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Basic information
Public title
A Cross-sectional study among Asymptomatic Long Term Low Dose Aspirin Users by using Video Capsule Endoscopy:
Acronym
CASTLE study
Scientific Title
A Cross-sectional study among Asymptomatic Long Term Low Dose Aspirin Users by using Video Capsule Endoscopy:
Scientific Title:Acronym
CASTLE study
Region
| Japan |
Condition
Condition
Small intestinal abmormalities in long-term low dose aspirin users
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate small intestinal abmormalities in long-term asymptomatic low dose aspirin users
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence rate of the small intestinal disease inlong-term asymptomatic low dose aspirin users.
Key secondary outcomes
1) Correlation between capsule endoscopic findings and laboratory data.
2) Correlation between capsule endoscopic findings and FOBT.
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
Long Term Low Dose Aspirin user
Key exclusion criteria
1) Ppatients with dysphagia.
2) Patients who have history of the ileus or stricture or fistula of the intestine.
3) Diagnosed Crohn's disease
4) Patient with pacemaker or other medical electronic equipment.
5)Patients who have history of multiple abdominal operation or radiation therapy.
6) Patients who can not give informed consent for operation to retrieve the capsule.
7) The patients who have severe heart failure and respiratory failure.
8)7) The patients who are prescribed warfarin, anti-platelate drugs or mucoprotective agents.
Target sample size
100
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 therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University
Division name
Center for Diagnostic therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
Keio University,Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Keio University,Division of Gastroenterology and Reseach fund of Mitsukoshi Health and welfare foundation.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、東京都済生会中央病院、けいゆう病院、日本鋼管病院、東京歯科大学市川総合病院、横浜市民病院、北里研究所病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 09 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
Capsule endoscopic findings
Management information
Registered date
| 2011 | Year | 09 | Month | 09 | Day |
Last modified on
| 2013 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007492
