UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062747 |
|---|---|
| Receipt number | R000071760 |
| Scientific Title | Data collection study on patients with respiratory tract infections (RTIs-2026-1) |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/31 14:58:04 |
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Basic information
Public title
Data collection study on patients with respiratory tract infections (RTIs-2026-1)
Acronym
Data collection study on respiratory tract infections
Scientific Title
Data collection study on patients with respiratory tract infections (RTIs-2026-1)
Scientific Title:Acronym
Data collection study on respiratory tract infections
Region
| Japan |
Condition
Condition
Acute upper respiratory tract infections (Influenza, COVID-19, Streptococcal pharyngitis, etc.)
Classification by specialty
| Medicine in general | Infectious disease | Chest surgery |
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a dataset of pharyngeal images and clinical information collected from patients with suspected respiratory tract infections, aiming to utilize it for the development and performance improvement of artificial intelligence-powered medical devices that assist in diagnosing respiratory tract infections and other diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
not applicable
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
1) Patients suspected of influenza, COVID-19, or streptococcal infection, who are scheduled for or have undergone at least one rapid diagnostic test for these infections at the clinic/hospital.
2) Patients aged 6 years or older at the time of informed consent (patients aged 4 years or older are eligible at participating pediatric clinics that have received necessary guidance from AICE Inc.).
3) Patients (or their legally acceptable representatives) who have provided voluntary written informed consent to participate in this study.
Key exclusion criteria
1) Patients with impaired consciousness or respiratory distress/failure.
2) Patients with moderate-to-severe periodontal/dental diseases or loose teeth that could worsen by using the study device.
3) Patients with trauma or injury to the maxillofacial region, teeth, oral cavity, or pharynx that could worsen by using the study device, or those who underwent surgery on these parts within 1 month.
4) Patients with persistent/recurrent vomiting.
5) Patients who have difficulty maintaining a sitting position for pharyngeal imaging.
6) Patients receiving medical care via home visits.
7) Patients judged to be unsuitable for participation by the principal investigator or sub-investigator.
Target sample size
14250
Research contact person
Name of lead principal investigator
| 1st name | Memori |
| Middle name | |
| Last name | Fukuda |
Organization
Aillis,Inc.
Division name
Clinical Research Promotion Office
Zip code
101-0042
Address
28-4 Kanda Higashimatsushitacho, Chiyoda-ku, Tokyo
TEL
03-5218-2374
clinicalresearch-promotion@aillis.jp
Public contact
Name of contact person
| 1st name | Memori |
| Middle name | |
| Last name | Fukuda |
Organization
Aillis,Inc.
Division name
Clinical Research Promotion Office
Zip code
101-0042
Address
28-4 Kanda Higashimatsushitacho, Chiyoda-ku, Tokyo
TEL
03-5218-2374
Homepage URL
clinicalresearch-promotion@aillis.jp
Sponsor or person
Institute
Aillis,Inc.
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
| 2026 | Year | 08 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection study on respiratory tract infections
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071760
