UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014584 |
|---|---|
| Receipt number | R000016962 |
| Scientific Title | The Evaluation of Wearable Spirometer |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2017/01/16 10:33:06 |
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Basic information
Public title
The Evaluation of Wearable Spirometer
Acronym
The Evaluation of Wearable Spirometer
Scientific Title
The Evaluation of Wearable Spirometer
Scientific Title:Acronym
The Evaluation of Wearable Spirometer
Region
| Japan |
Condition
Condition
healthy male adults
Classification by specialty
| Pneumology | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of Wearable Spirometer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spirometry
percutaneous oxygen saturation
Key secondary outcomes
Questionnaire (height, body weight, history of smoking, impression of this examination)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The spirometry using the wearable spirometer will be performed in addition to a routine spirometry, and the results will be compared under the resting condition, the exercise tolerance with 10 min walking or brisk walking, and the weight-bearing (up to 2 kg).
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
Key inclusion criteria
Healthy male adults aged 20 years or more
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
30
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
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
matsu@met.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Pathophysiological Laboratory Sciences
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Aichi Science & Technology Foundation
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
| 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 | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 17 | Day |
Last modified on
| 2017 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016962
