UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2019 Year 01 Month 09 Day
Date of IRB	2018 Year 01 Month 08 Day
Anticipated trial start date	2019 Year 01 Month 10 Day
Last follow-up date	2019 Year 03 Month 29 Day
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 09 Month 09 Day

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