UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030150 |
|---|---|
| Receipt number | R000034424 |
| Scientific Title | Assessment of GI tract function using rapid MRI |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2017/11/28 15:29:48 |
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Basic information
Public title
Assessment of GI tract function using rapid MRI
Acronym
GI MRI functional assessment
Scientific Title
Assessment of GI tract function using rapid MRI
Scientific Title:Acronym
GI MRI functional assessment
Region
| Japan |
Condition
Condition
Gastrointestinal motility disorder
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop analytical methods numerically extracting multidimensional features of gastrointestinal motility in MRI videos. The analytical methods may enable to combine information on gastrointestinal motility among institutions.
Basic objectives2
Others
Basic objectives -Others
Information regarding features of gastrointestinal motility by taking functional food, etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To gain MRI analytical methods numerically and sensitively extracting multidimensional features of gastrointestinal motility (after assessment of applicability of various image analyses)
Key secondary outcomes
To reveal the influence of food to multidimensional gastrointestinal motility
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Commercial liquid meal (200 ml, 200 kcal) mixed with commercial oligo-saccharide (12g)
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) Adult male and female who understand the study plan and agree with a written informed consent
2) Unpaid participants recruited by poster display etc in the Hospital performing rapid MRI
3) Consideration of reward (approximately 1000 yen/hour) in case of shortage of participants
Key exclusion criteria
1) Those who are suspected unhealthy on the day of the MRI measurement
2) Those who do not understand the study plan, or those who disagree with a written informed consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Nakayama |
Organization
Nagoya University
Division name
Graduate School of Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2045
h44673a@nucc.cc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemi Teramoto |
Organization
Kojin Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-710 Shikenya-cho, Moriyama-ku, Nagoya
TEL
052-771-2151
Homepage URL
hteramoto@kojin-hospital.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Kojin Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University Graduate School of Medicine
Name of secondary funder(s)
R-Tech Corporation
IRB Contact (For public release)
Organization
Address
Tel
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
絋仁病院（愛知県）、名古屋大学大学院医学系研究科（愛知県）
(Kojin Hospital, Aichi; Nagoya University, Aichi)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034424
| 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 |
