UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007596 |
|---|---|
| Receipt number | R000008971 |
| Scientific Title | The study of mucosal membrane in colonic peridiverticular area |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/02/08 00:23:15 |
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Basic information
Public title
The study of mucosal membrane in colonic
peridiverticular area
Acronym
The study of mucosal membrane in colonic
peridiverticular area
Scientific Title
The study of mucosal membrane in colonic
peridiverticular area
Scientific Title:Acronym
The study of mucosal membrane in colonic
peridiverticular area
Region
| Japan |
Condition
Condition
Colonic diverticular disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the presence or absence of inflammatory cell infiltrate, fibrosis, neoangiogenesis in mucosal membrane of cononic peridiverticular area.
Basic objectives2
Others
Basic objectives -Others
Correlation with symptoms
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the presence or absence of
inflammatory cell infiltrate, fibrosis,
neoangiogenesis in mucosal membrane of
colonic perdiverticular area
Key secondary outcomes
To assess the presence or absence of
correlation with symptoms
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Biopsy of mucosal membrane of colonic peridiverticular area
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with colonic diverticula who
have agreement of our study and undergo
colonoscopy
Key exclusion criteria
Patients who take antiplatelets or
anticoagulants
Patients with inflammatory bowel disease
Cancer patients
Patients who have history of colonic surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Yamada |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama
TEL
0457872640
eiji@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yamada |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama
TEL
0457872640
Homepage URL
eiji@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine, Gastroenterology Division
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008971
