UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039105 |
|---|---|
| Receipt number | 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 18:12:49 |
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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
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
kentaro2316@live.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044592
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
