UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011201 |
|---|---|
| Receipt number | 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 16:27:21 |
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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
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
h.yano@clin.med.tokushima-u.ac.jp
Public contact
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
h.yano@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima Hospital
gastroenterological medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012983
