Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062747) titled 'Data collection study on patients with respiratory tract infections (RTIs-2026-1)' on Aug. 31.

Study Type: Observational

Primary Sponsor: Institute - Aillis,Inc.

Condition: Condition - Acute upper respiratory tract infections (Influenza, COVID-19, Streptococcal pharyngitis, etc.) Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 14250

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071760

Disclaimer: Curated by HT Syndication.