UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014612
Receipt number 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 10:16:15

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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 or person

Institute

Department of Pathophysiological Laboratory Sciences
Nagoya University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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