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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013431
Receipt No. 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

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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
Email 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
Email mkikuchi@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Nagoya University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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