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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017544
Receipt No. 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

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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
Email 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
Email watanabe@met.nagoya-u.ac.jp

Sponsor
Institute Nagoya university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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