UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Evaluation of Wearable Spirometer
Title of the study (Brief title)	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	Tsutomu Kawabe
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pathophysiological Laboratory Sciences
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	Miyoko Matsushima
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pathophysiological Laboratory Sciences
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016962