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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003349
Receipt No. R000004030
Scientific Title Small Intestinal Surveillance of Chronic Hemodialysis Patients using Video Capsule Endoscopy
Date of disclosure of the study information 2010/03/17
Last modified on 2011/09/09

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Basic information
Public title Small Intestinal Surveillance of Chronic Hemodialysis Patients using Video Capsule Endoscopy

Acronym SCHEMA study
Scientific Title Small Intestinal Surveillance of Chronic Hemodialysis Patients using Video Capsule Endoscopy

Scientific Title:Acronym SCHEMA study
Region
Japan

Condition
Condition Small intestinal abmormalities in chronic hemodialysis patients
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate small intestinal abmormalities in chronic hemodialysis patients
Basic objectives2 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 in patients with chronic hemodialysys.
Key secondary outcomes 1) Correlation between capsule endoscopic findings and laboratory data.
2) Correlation between capsule endoscopic findings and administration dose of EPO and Fe.
3) One-year follow up study after capsule endoscopy.


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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chronic hemodialysis Patients
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) Patient who have history of CAPD or CAPD patients.
6) Patients who have history of multiple abdominal operation or radiation therapy.
7) Patients who can not give informed consent for operation to retrieve the capsule.
8) The patients who have severe heart failure and respiratory failure.
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 Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Keio University,Division of Gastroenterology
Institute
Department

Funding Source
Organization Division of Gastroenterology, Keio University.
Capsule provider is Given Imaging Ltd.
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
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 多摩永山腎内科クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 17 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
2010 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information To investigate small intestinal abmormalities in chronic hemodialysis patients using video capsule endoscopy

Management information
Registered date
2010 Year 03 Month 17 Day
Last modified on
2011 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004030

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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