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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011201
Receipt No. R000012983
Scientific Title Obscure gastrointestinal bleeding with Hereditary polyposis syndrome of small intestinal disease with video-capsule endoscopy and double ballon endoscopy
Date of disclosure of the study information 2013/07/31
Last modified on 2013/08/26

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Basic information
Public title Obscure gastrointestinal bleeding with Hereditary polyposis syndrome of small intestinal disease with video-capsule endoscopy and double ballon endoscopy
Acronym Hereditary polyposis syndrome of small intestinal disease with video-capsule endoscopy and double ballon endoscopy
Scientific Title Obscure gastrointestinal bleeding with Hereditary polyposis syndrome of small intestinal disease with video-capsule endoscopy and double ballon endoscopy
Scientific Title:Acronym Hereditary polyposis syndrome of small intestinal disease with video-capsule endoscopy and double ballon endoscopy
Region
Japan

Condition
Condition Familial adenomatous polyposis(FAP) and Peutz-Jeghers syndrome(PJS)
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 video-capsule endoscopy(VCE) and double ballon endoscopy(DBE)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes imaging procedure of video-capsule endoscopy(VCE) and double ballon endoscopy(DBE)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 We observe the small intestine with a capsule endoscope and the double balloon small intestine endoscope for FAP and PJS patients with unidentified gastrointestinal bleeding by the inspection of the upper part and the lower part gastrointestinal tract and examine the frequency of the small intestine polyp.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria fap and pjs of fifteen years old or older

not stenosis of small intestine

unidentified gastrointestinal bleeding
Key exclusion criteria stenosis of small intestine

Gastrointestinal hypokinesia

The person who buries medical equipment
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name tetuji takayama
Organization University of Tokushima Hospital
Division name gastroenterological medicine
Zip code
Address 3-18-15, Kuramotocho, Tokushima-shi
TEL 088-633-7124
Email h.yano@clin.med.tokushima-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name hiromi yano
Organization University of Tokushima Hospital
Division name gastroenterological medicine
Zip code
Address 3-18-15, Kuramotocho, Tokushima-shi
TEL 088-633-7124
Homepage URL
Email h.yano@clin.med.tokushima-u.ac.jp

Sponsor
Institute University of Tokushima Hospital
gastroenterological medicine
Institute
Department

Funding Source
Organization University of Tokushima Hospital
gastroenterological medicine
Organization
Division
Category of Funding Organization Non profit foundation
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
2013 Year 07 Month 31 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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 16 Day
Last modified on
2013 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012983

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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