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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001696
Receipt No. R000002039
Scientific Title A small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Date of disclosure of the study information 2009/02/09
Last modified on 2010/12/24

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Basic information
Public title A small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Acronym Small amount of PEG for capsule endoscopy
Scientific Title A small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Scientific Title:Acronym Small amount of PEG for capsule endoscopy
Region
Japan

Condition
Condition small intestinal disorders
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of a small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes image quality of capsule endoscopy
Key secondary outcomes completion rate to the cecum

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 To ingest 500ml of polyethylene glycol solution within a 2-h period starting 30 minutes after swallowing the capsule
Interventions/Control_2 To ingest no polyethylene glycol solution
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 subjects with gastrointestinal bleeding who have no hemorrhage-causing lesions on gastroscopy and total colonoscopy
Key exclusion criteria subjects with a history of small bowel resection.
subjects with or suspected for intestinal stenosis.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Matsuhashi
Organization Kanto Medical Center, NTT East
Division name Department of Gastroenterology
Zip code
Address 5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL 03-3448-6245
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanto Medical Center, NTT East
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email nmatuha-tky@umin.ac.jp

Sponsor
Institute Kanto Medical Center, NTT East
Institute
Department

Funding Source
Organization Kanto Medical Center, NTT East
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 09 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
2009 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 09 Day
Last modified on
2010 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002039

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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