UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000037018