UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052896 |
|---|---|
| Receipt number | R000060354 |
| Scientific Title | Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19 |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/05/30 10:51:09 |
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Basic information
Public title
Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19
Acronym
Data collection clinical studies, regarding influenza or COVID-19
Scientific Title
Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19
Scientific Title:Acronym
Data collection clinical studies, regarding influenza or COVID-19
Region
| Japan |
Condition
Condition
Seasonal influenza
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Collect pharyngeal images and clinical information from patients suspected of having influenza or COVID-19 and create a dataset for use in development, etc. (including performance evaluation tests in applications for regulatory approval), including performance improvement of medical devices using artificial intelligence for the diagnosis of influenza or COVID-19, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-
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
| 4 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who present to the outpatient clinic of the Principal Investigator or Co-Investigator (excluding Aillis, Inc.) with complaints of fever and airway symptoms and who fulfil all of the following 1), 2), 3) and 4) will be included in the study. If the patient is seen again with similar symptoms during the study period, he/she may be enrolled in the study again.
1) Persons who have undergone antigen qualitative testing for influenza and novel coronavirus with suspected influenza or COVID-19.
2) Persons aged 4 years or older at the time consent is obtained
3) Persons who have obtained the free written consent of the individual or a surrogate to participate in this study
4) Persons who fall under one or more of the following items from (1) to (4) (however, for items (1) to (3), only persons within 48 hours of the onset of symptoms are counted under the relevant item)
(i) Fever of 37.0 C or more (including cases where the temperature exceeded 37 C measured at home, etc.)
(ii) With systemic symptoms such as arthralgia, myalgia, headache, or general malaise, anorexia, etc.
(iii) Respiratory symptoms with cough, sore throat or nasal discharge/nasal obstruction
(iv) Suspected of having influenza or COVID-19 according to a doctor's judgement, such as through concentrated contact with a patient who has influenza or COVID-19
Key exclusion criteria
1) Persons with impaired consciousness or breathing disorders (respiratory failure)
2) Persons with moderate or severe gingival or dental disease or upset teeth that may be aggravated by the use of the research equipment
3) Persons with trauma or damage to the maxillofacial, dental, oral or pharyngeal regions that may be aggravated by the use of the research equipment, or who have undergone surgery on these parts within one month
4) Persons who repeatedly vomit.
5) Other persons who are judged by the principal investigator or research assistant to be unsuitable as subjects for the study
Target sample size
4600
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Nakadai |
Organization
Medical Corporation, Shoseikai, Fukuda Internal Medicine
Division name
-
Zip code
335-0015
Address
2-7-30, Kawagishi, Toda-shi, Saitama
TEL
048-431-3737
fukudanaika8915@gmail.com
Public contact
Name of contact person
| 1st name | Memori |
| Middle name | |
| Last name | Fukuda |
Organization
Aillis,Inc.
Division name
-
Zip code
104-0028
Address
Yaesu Central Tower 7F, 2-2-1 Yaesu, Chuo-ku, Tokyo 104-0028, Japan
TEL
03-5218-2374
Homepage URL
clinicalresearch_flucov2023_01@aillis.jp
Sponsor or person
Institute
Medical Corporation, Shoseikai, Fukuda Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Aillis,Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic
Address
Toranomon 36 Mori Building 7F, 3-4-7 Toranomon, Minato-ku, Tokyo-to 105-0001 Japan
Tel
03-6777-1490
c-irb_ug@neues.co.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
| 2023 | Year | 12 | 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
4334
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection clinical studies, including pharyngeal imaging
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060354
