UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038376 |
|---|---|
| Receipt number | R000043734 |
| Scientific Title | Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water by ultrasound asseement of gastric volume. |
| Date of disclosure of the study information | 2019/10/24 |
| Last modified on | 2021/10/25 15:17:49 |
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Basic information
Public title
Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water by ultrasound asseement of gastric volume.
Acronym
Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water.
Scientific Title
Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water by ultrasound asseement of gastric volume.
Scientific Title:Acronym
Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the difference of gastric transit time after ingestion of Aquafun and Arginaid Water.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cross-sectional surface area of
the gastric antrum measured by ultrasound.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of Aquafun and Arginaid Water.
Interventions/Control_2
The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of Aquafun and Arginaid Water.
Interventions/Control_3
The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 12.5% Sucrose solution.(Control)
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
Key inclusion criteria
Persons who fills everything the following
1) a person of 20years or more
2) a person who gives written Informed consent
Key exclusion criteria
1. a person who have gastrointestinal lesion.
2. a person who are ineligible in the opinion of the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Okabe |
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Division name
Department of Anesthesiology
Zip code
312-0057
Address
20-1 Ishikawa-cho Hitachinaka-shi
TEL
029-354-5111
t-okabe@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Okabe |
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Division name
Department of Anesthesiology
Zip code
312-0057
Address
20-1 Ishikawa-cho Hitachinaka-shi
TEL
029-354-5111
Homepage URL
t-okabe@nms.ac.jp
Sponsor or person
Institute
Hitachi, Ltd. Hitachinaka General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi General Hospital Research Ethics Committee
Address
2-1-1 jyonan-cho Hitachi-shi Ibaraki 317-0077 JAPAN
Tel
029-423-8333
masahiro.miura.cz@hitachi.com
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 | 10 | Month | 24 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparing to submit
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 | 08 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 24 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043734
| 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 |
