UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031776 |
|---|---|
| Receipt number | 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 | 2020/03/01 19:30:21 |
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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
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
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine,
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
| 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
| 2020 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036273
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
