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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039105
Receipt No. R000044592
Scientific Title Prospective trial to safety of gastric pressure measurement
Date of disclosure of the study information 2020/04/01
Last modified on 2021/01/12

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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/ctr_e/ctr_view.cgi?recptno=R000044592

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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