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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032467
Receipt No. R000037018
Scientific Title Assessment of non-contact screening system for chronic obstructive pulmonary disease using Doppler radar
Date of disclosure of the study information 2018/05/14
Last modified on 2019/05/13

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Basic information
Public title Assessment of non-contact screening system for chronic obstructive pulmonary disease using Doppler radar
Acronym Non-contact screening system for COPD
Scientific Title Assessment of non-contact screening system for chronic obstructive pulmonary disease using Doppler radar
Scientific Title:Acronym Non-contact screening system for COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of the non-contact COPD screening system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation of percent predicted forced expiratory volume in one second between spirometer and non-contact COPD screening system
Key secondary outcomes The comparison of patterns for flow volume curves between spirometry and non-contact COPD screening system.
The comparison of forced expiratory flow at 50% vital capacity (V50) and forced expiratory flow at 25% vital capacity (V25) between spirometry and non-contact COPD screening system.

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 Assessment of percent predicted forced expiratory volume in one second using non-contact screening system
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. COPD was diagnosed based on the Japanese Respiratory Society guidelines for the diagnosis and treatment of COPD, 4th Edition.
2. Ex-smokers.
3. Patients who were stable for more than 4 weeks without COPD related exacerbations.
4. Patients 40 years and over.
5. Patients who agreed to participate in this study with written informed consent.
Key exclusion criteria 1. Patients with asthma, tuberculosis, sever heart diseases and active malignant tumor.
2. Patients who are or may be pregnant.
3. Any other cases regarded as inadequate for study enrollment by the investigators.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Masamichi
Middle name
Last name Mineshita
Organization St. Marianna University School of
Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
TEL 044-977-8111
Email m-mine@marianna-u.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Nishine
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
TEL 044-977-8111
Homepage URL
Email h2nishine@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan University
University of Electro-Communications
HUAWEI Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna University School of Medicine, Division of Graduate Student Affairs and Research Promotion
Address 2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.ac.jp

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
2018 Year 05 Month 14 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 84
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
2018 Year 03 Month 29 Day
Date of IRB
2018 Year 03 Month 29 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 03 Day
Last modified on
2019 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=R000037018

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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