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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014612
Receipt No. R000017004
Scientific Title The evaluation of the spirometer equipped with guidance for best practice
Date of disclosure of the study information 2014/09/01
Last modified on 2015/07/17

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Basic information
Public title The evaluation of the spirometer equipped with guidance for best practice
Acronym The evaluation of the spirometer equipped with guidance for best practice
Scientific Title The evaluation of the spirometer equipped with guidance for best practice
Scientific Title:Acronym The evaluation of the spirometer equipped with guidance for best practice
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Pneumology Laboratory medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of the spirometer equipped with guidance for best practice
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes spirometry
Key secondary outcomes Questionnaire (height, body weight, history of smoking, impression of this examination)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The spirometry with computer-guided navigation will be performed, and the results will be compared with those examined by the medical technologist.
first; the spirometry with computer-guided navigation, second; the spirometry examined by the medical technologist
Interventions/Control_2 The spirometry with computer-guided navigation will be performed, and the results will be compared with those examined by the medical technologist.
first; the spirometry examined by the medical technologist, second; the spirometry with computer-guided navigation
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults: between 20 and 80 years of age
Those who is able to read and understand the Informed Consent Form and will sign the Informed Consent.
Key exclusion criteria Those who feel uncomfortable during the study
Those who are judged inappropriate for the cooperation of this study by the investigator in charge
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Kawabe
Organization Nagoya University Graduate School of Medicine
Division name Department of Pathophysiological Laboratory Sciences
Zip code
Address 1-1-20 Daikou-minami, Higashi-ku, Nagoya, 461-8673, Japan
TEL 052-719-1547
Email kawabe@met.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyoko Matsushima
Organization Nagoya University Graduate School of Medicine
Division name Department of Pathophysiological Laboratory Sciences
Zip code
Address 1-1-20 Daikou-minami, Higashi-ku, Nagoya, 461-8673, Japan
TEL 052-719-1197
Homepage URL
Email matsu@met.nagoya-u.ac.jp

Sponsor
Institute Department of Pathophysiological Laboratory Sciences
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization DENSO Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 09 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 Completed
Date of protocol fixation
2014 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 22 Day
Last modified on
2015 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017004

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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