UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017544 |
|---|---|
| Receipt number | R000020335 |
| Scientific Title | Objective assessment of bowel movement of home-care patients using portable bowel action potential devise |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2015/05/13 17:34:33 |
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Basic information
Public title
Objective assessment of bowel movement of home-care patients using portable bowel action potential devise
Acronym
Objective assessment of bowel movement of home-care patients using portable bowel action potential devise
Scientific Title
Objective assessment of bowel movement of home-care patients using portable bowel action potential devise
Scientific Title:Acronym
Objective assessment of bowel movement of home-care patients using portable bowel action potential devise
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the field of home care and home nursing, as diagnosis and pathology evaluation of bowel function, peristalsis, the abdominal pain, bowel movement frequency, excretion or the shape of the stool et al are measured. However, the subjective diagnosis is limited. Then, we created a small and simple "portable bowel electrometer". In this study, we attempt an objective evaluation of home care's bowel function using a portable bowel electrometer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intestinal potential, electrocardiogram, bowel sounds, questionnaire
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The patients wear the portable bowel electrometer for 9 hours, and the intestinal potential, electrocardiogram and bowel sounds are measured.
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
| 60 | years-old | <= |
Age-upper limit
| 89 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The elderly who are receiving outpatient rehabilitation or use the home-visit nursing station
Key exclusion criteria
It is difficult to join the experiment in free will.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo WATANABE |
Organization
Nagoya university
Division name
medical laboratory sciences
Zip code
Address
1-1-20 Daiko-Minami, Higashi-ku, Nagoya City, Aichi
TEL
090-7596-3800
watanabe@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo WATANABE |
Organization
Nagoya university
Division name
medical laboratory sciences
Zip code
Address
1-1-20 Daiko-Minami, Higashi-ku, Nagoya City, Aichi
TEL
090-7596-3800
Homepage URL
watanabe@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Medical Home Care Services Agency
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 13 | 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
| 2015 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | 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
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020335
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| Registered date | File name |
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