UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032467 |
|---|---|
| Receipt number | 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 17:29:20 |
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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
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
h2nishine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
