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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025024
Receipt No. R000028715
Scientific Title Clinical utility and safety of a prototype 3D endoscope
Date of disclosure of the study information 2017/01/04
Last modified on 2016/11/28

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Basic information
Public title Clinical utility and safety of a prototype 3D endoscope
Acronym Clinical utility and safety of a prototype 3D endoscope
Scientific Title Clinical utility and safety of a prototype 3D endoscope
Scientific Title:Acronym Clinical utility and safety of a prototype 3D endoscope
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 safety of a prototype 3D endoscope
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complications
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 endoscopy
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 nothing
Key exclusion criteria nothing
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosuke Nomura
Organization toranomon hospital
Division name Department of Gastroenterology
Zip code
Address 2-2-2 Toranomon, MInato-ku, Tokyo
TEL 03-3588-1111
Email med20365nomura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Nomura
Organization toranomon hospital
Division name Department of Gastroenterology
Zip code
Address 2-2-2 Toranomon, MInato-ku, Tokyo
TEL 03-3588-1111
Homepage URL
Email med20365nomura@yahoo.co.jp

Sponsor
Institute toranomon hospital
Institute
Department

Funding Source
Organization toranomon hospital
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 04 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 28 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028715

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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