UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042198 |
|---|---|
| Receipt number | R000048167 |
| Scientific Title | Basic study on bowel sounds and the defecation cycle |
| Date of disclosure of the study information | 2020/10/21 |
| Last modified on | 2023/10/24 09:08:11 |
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Basic information
Public title
Basic study on bowel sounds and the defecation cycle
Acronym
Study on bowel sounds and the defecation
Scientific Title
Basic study on bowel sounds and the defecation cycle
Scientific Title:Acronym
Basic study on bowel sounds and the defecation cycle
Region
| Japan |
Condition
Condition
hospitalized patient at our university
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test the relationship between bowel sounds recorded by a wireless device and the defecation cycle whether bowel sounds are able to predict the defecation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bowel sounds
Key secondary outcomes
Defecation record
Basic information such as height
Echo images of the lower digestive organs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Bowel sounds
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Participants who have understood the study procedures and aims and given written informed consent by themselves after receiving a detailed explanation of the study.
2.(Healthy people) Those with no current lower digestive system problems
Key exclusion criteria
1. Patients whose skin condition around the abdomen is so bad that it is difficult to attach the sensor.
2.Other symptoms as inappropriate judged by the research director.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation medicine I, School of medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Koyama |
Organization
Fujita Health University
Division name
School of health sciences
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-9000
Homepage URL
cent-rsh@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Aichi Science & Technology Foundation: Aichi Synchrotron Radiation Center, Knowledge Hub Aichi Priority Research Project
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.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 | 10 | Month | 21 | 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
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048167
| 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 |
