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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006320
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Keio University,Division of Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007492

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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