UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043546 |
|---|---|
| Receipt number | R000049731 |
| Scientific Title | Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2021/03/30 14:53:06 |
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Basic information
Public title
Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Acronym
Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Scientific Title
Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Scientific Title:Acronym
Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Region
| Japan |
Condition
Condition
i) SARS-CoV-2 PCR positive COVID-19 patient
ii) Heart failure
iii) Sleep apnea syndrome
iv) Asthma
v) Chronic obstructive pulmonary disease
vi) Intestinal pneumonia
vii) Pulmonary mycobacterium avium complex disease
viii) Pediatric inguinal hernia
ix) Congenital cystic disease of lung
x) Pediatric metastatic lung tumors
xi) Pneumonia
Classification by specialty
| Cardiology | Pneumology | Infectious disease |
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a developed wearable biosensor compared with an existing reference medical device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pulse rate and SpO2
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
i) SARS-CoV-2 PCR positive COVID-19 patient
ii) Heart failure
iii) Sleep apnea syndrome
iv) Asthma
v) Chronic obstructive pulmonary disease
vi) Intestinal pneumonia
vii) Pulmonary mycobacterium avium complex disease
viii) Pediatric inguinal hernia
ix) Congenital cystic disease of lung
x) Pediatric metastatic lung tumors
xi) Pneumonia
Key exclusion criteria
1) Cannot use a developed medical device
2) Cannot obtain a written informed consent because of severe medical conditions (e.g. intubated)
3) Principle investigators considered inappropriate for eligibility
4) Pneumonia patients with A-DROP score equal or more than 3
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Innovative Clinical Research Center / Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
0762652049
anomura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Innovative Clinical Research Center / Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
0762652049
Homepage URL
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology (AIST), Keio University, Tohoku University, Nagoya University, CureApp Inc, Cosmic M.E. Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
0762652110
rinri@adm.kanazawa-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
金沢大学附属病院(石川県)、慶應大学病院(東京都)、東北大学病院(宮城県)、名古屋大学医学部附属病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 08 | 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
| 2021 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
This study will start on March 8, 2021.
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049731
