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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035500
Receipt No. R000040447
Scientific Title Prospective trial to measurement of intragastric pressure
Date of disclosure of the study information 2019/01/10
Last modified on 2019/01/10

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Basic information
Public title Prospective trial to measurement of intragastric pressure
Acronym Prospective trial to measurement of intragastric pressure
Scientific Title Prospective trial to measurement of intragastric pressure
Scientific Title:Acronym Prospective trial to measurement of intragastric pressure
Region
Japan

Condition
Condition non atrophic gastritis, atrophic gastritis, gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantitative analysis to the measurement of intragastric pressure when we observed strong extension of the gastric wall during endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quantitative analysis to the measurement of intragastric pressure when we observed strong extension of the gastric wall that is defined full extension of the folds on the greater curvature of the gastric corpus
Key secondary outcomes

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 Patients who undergo upper gastrointestinal endoscopy.
Patients who were over 20 years.
Patients who were eligible to this study criteria with written informed consent signed and dated.
Key exclusion criteria Patients who have risk factor of bleeding.
Patients who have history of distal or gastorectomy.
Patients who are not eligible to this study due to psychotic disease or psychological symptoms.
Patients whom doctor decide not to register to this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suketo So
Organization Tobata Kyoritsu Hospital
Division name Department of Gastroenterology
Zip code
Address 2-5-1, Sawami, Kitakyusyu-city, Fukuoka, Japan
TEL 093-871-5421
Email suketo1231@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Imamura
Organization Tobata Kyoritsu Hospital
Division name Department of Gastroenterology
Zip code
Address 2-5-1, Sawami, Kitakyusyu-city, Fukuoka, Japan
TEL 093-871-5421
Homepage URL
Email kentaro2316@live.jp

Sponsor
Institute Tobata Kyoritsu Hospital
Institute
Department

Funding Source
Organization none
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
2019 Year 01 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is prospective and observational study to measurement of intragastric pressure when we observed strong extension of the gastric wall

Management information
Registered date
2019 Year 01 Month 09 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040447

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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