UMIN-CTR Clinical Trial

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

Condition
Condition	Stomach
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the safety and efficacy of inflating a pressure of 20mmHg into the stomach during upper gastrointestinal endoscopy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint of this study is to evaluate the safety of inflating a pressure of 20mmHg into the stomach during upper gastrointestinal endoscopy.
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	1.Patients who undergo upper gastrointestinal endoscopy. 2.The patients whose ECOG performance statues should be 0 or 1. 3.Patients who were over 20 years. 4.Patients who were eligible to this study criteria with written informed consent signed and dated.
Key exclusion criteria	1.Patients who have risk factor of bleeding. 2.Patients who have history of distal or gastorectomy. 3.Patients with serious underlying disease. 4.Patients who are not eligible to this study due to psychotic disease or psychological symptoms. 5.Patients whom doctor decide not to register to this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kenshi Middle name Last name Yao
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Endoscopy
Zip code	818-0067
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL	092-921-101
Email	yao@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Imamura
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Endoscopy
Zip code	818-0067
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL	092-921-1011
Homepage URL
Email	kentaro2316@live.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Chikushi 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	Fukuoka University Chikushi Hospital
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka
Tel	092-921-1011
Email	kentaro2316@live.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	2020 Year 04 Month 01 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	2020 Year 01 Month 08 Day
Date of IRB	2020 Year 08 Month 13 Day
Anticipated trial start date	2020 Year 08 Month 14 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The intragastric pressure measurement will be performed by injecting 20 mL of tap water once, washing the forceps hole interior, and suctioning the tap water in the forceps hole for 10 s.

Management information
Registered date	2020 Year 01 Month 09 Day
Last modified on	2021 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044592