UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001378 |
|---|---|
| Receipt number | R000001669 |
| Scientific Title | Identification of small intestinal diseases in cases positive for stool occult blood |
| Date of disclosure of the study information | 2008/09/18 |
| Last modified on | 2010/09/17 12:50:40 |
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Basic information
Public title
Identification of small intestinal diseases in cases positive for stool occult blood
Acronym
Small intestinal diseases in cases positive for stool occult blood
Scientific Title
Identification of small intestinal diseases in cases positive for stool occult blood
Scientific Title:Acronym
Small intestinal diseases in cases positive for stool occult blood
Region
| Japan |
Condition
Condition
small intestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search for small intestinal disorders in cases with positive fecal oocult blood test and negative gastroscopy/colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of small intestinal disorders determined by capsule endoscopy performed within 4 months after positive fecal occult blood test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform capsule endoscopy in cases with positive fecal occult blood test and negative gastroscopy and colonoscopy during 2008.9.16 and 2009.9.15
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases with positive fecal occult blood test and negative gastroscopy and colonoscopy
Key exclusion criteria
cases with known small intestinal disorders or Crohn's disease
cases with or suspected for intestinal stenosis
cases with implanted cardiac pacemaker or other electronic medical instruments
cases with swallowing disturbance
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
Public contact
Name of contact person
| 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
Homepage URL
nmatuha-tky@umin.ac.jp
Sponsor or person
Institute
Kanto Medical Center, NTT East
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
| 2008 | Year | 09 | Month | 18 | 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
| 2008 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 17 | Day |
Last modified on
| 2010 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001669
