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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031776
Receipt No. R000036273
Scientific Title System of 3-dimensional model of stomach using endoscopic images
Date of disclosure of the study information 2018/03/17
Last modified on 2019/04/24

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Basic information
Public title System of 3-dimensional model of stomach using endoscopic images
Acronym Three dimensional model of stomach
Scientific Title System of 3-dimensional model of stomach using endoscopic images
Scientific Title:Acronym Three dimensional model of stomach
Region
Japan

Condition
Condition Patients who undergo esophagogastroduodenoscopy(EGD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Developing the system of 3-dimensional model of stomach using EGD images
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Developing the system of 3-dimensional model of stomach using EGD images
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Esophagogastroduodenoscopy (EGD)
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 1) Undergoing EGD under intravenous sedation
2) Aged 20-80 years
3) Written informed consent
Key exclusion criteria 1) Severe co-morbidities
2) A history of gastric surgery
3) Lack of informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Sho
Middle name
Last name Suzuki
Organization Nihon University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code 101-8309
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL 03-3293-1711
Email s.sho.salubriter.mail@gmail.com

Public contact
Name of contact person
1st name Sho
Middle name
Last name Suzuki
Organization Nihon University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code 101-8309
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL 03-3293-1711
Homepage URL
Email s.sho.salubriter.mail@gmail.com

Sponsor
Institute Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine,
Institute
Department

Funding Source
Organization Self funding
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 Institutional Review Board of Nihon University Hospital
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
Tel 03-3293-1711
Email nuhosp.rinri@nihon-u.ac.jp

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
2018 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 5
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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 08 Day
Date of IRB
2018 Year 03 Month 08 Day
Anticipated trial start date
2018 Year 03 Month 19 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 17 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036273

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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