UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013431 |
|---|---|
| Receipt number | R000015681 |
| Scientific Title | Efficacy to observe duodenal diseases using Endo-Cytoscopy-System in vivo |
| Date of disclosure of the study information | 2014/03/17 |
| Last modified on | 2016/03/15 20:52:34 |
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Basic information
Public title
Efficacy to observe duodenal diseases using Endo-Cytoscopy-System in vivo
Acronym
Efficacy to observe duodenal diseases using Endo-Cytoscopy-System in vivo
Scientific Title
Efficacy to observe duodenal diseases using Endo-Cytoscopy-System in vivo
Scientific Title:Acronym
Efficacy to observe duodenal diseases using Endo-Cytoscopy-System in vivo
Region
| Japan |
Condition
Condition
duodenal adenoma,early duodenal carcinoma,malignant lymphoma of the duodenum
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effficacy and safety to observe duodenal diseases using Endo-Cytoscopy-System(ECS) in vivo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity
Key secondary outcomes
The specificity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Over 20 years old person who will undergo treatment for duodenal adenoma, early duodenal carcinoma and malignant lymphoma of the duodenum.
Key exclusion criteria
1.The patients with severe complication
2.The patients who the physitian judged as inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
Nagoya University Graduate School
Division name
Department of Gastroenterology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2172
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Kikuchi |
Organization
Nagoya University Graduate School
Division name
Department of Gastroenterology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2784
Homepage URL
mkikuchi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Nagoya University Graduate School of Medicine
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the efficacy and safety to observe duodenal adenoma, early duodenal carcinoma and malignant lymphoma of the duodenum using ECS in vivo.
Management information
Registered date
| 2014 | Year | 03 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015681
