UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014033 |
|---|---|
| Receipt number | R000016342 |
| Scientific Title | Evaluation of usefullness of micro vessals findings by endocytoscope |
| Date of disclosure of the study information | 2014/05/25 |
| Last modified on | 2015/11/22 10:15:17 |
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Basic information
Public title
Evaluation of usefullness of micro vessals findings by endocytoscope
Acronym
Evaluation of usefullness of micro vessals findings by endocytoscope
Scientific Title
Evaluation of usefullness of micro vessals findings by endocytoscope
Scientific Title:Acronym
Evaluation of usefullness of micro vessals findings by endocytoscope
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify endocytoscopic findings of surface blood vessels in lesions of the large intestine that can be visualized by EC and thereby to examine the clinical significance of those ultra-high magnification findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To discover microvessal findings of submucosal deep invasion cancer in large intestin by endocytoscope
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To diagnosis colorectal tumor by NBI- endocytoscope.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal neoplastic lesions .
Key exclusion criteria
1.Patients who are taking antiplatelet or anticoagulant
2. Patients with inflammatory bowel disease.
3. Patients disagree with informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ei Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakichuo, Tsuzuki, Yokohama,Kanagawa,Japan
TEL
045-949-7000
n_k2601@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Nakamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakichuo, Tsuzuki, Yokohama,Kanagawa,Japan
TEL
045-949-7000
Homepage URL
n-hiroki@td6.so-net.ne.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 05 | Month | 25 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2015 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016342
