Clinical Trial: Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19 (flu-cov-2025-1) (Japan)

Tokyo, Dec. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060167) titled 'Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19 (flu-cov-2025-1)' on Dec. 22.

Study Type: Observational

Primary Sponsor: Institute - Medical Corporation, Shoseikai, Fukuda Internal Medicine

Condition: Condition - Seasonal influenza COVID-19 Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 4 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Persons who have undergone antigen qualitative testing for influenza and novel coronavirus with suspected influenza or COVID-19. 2) Persons aged 6 years or older at the time consent is obtained (however, persons 4 years of age or older may be accepted at pediatric clinics that have received the necessary explanation from Iris Corporation). 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) Persons who have difficulty in taking pictures in a sitting position. 6) Persons who are receiving house calls. 7) Other persons who are judged by the principal investigator or research assistant to be unsuitable as subjects for the study Target Size - 1900

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 12 Month 03 Day Date of IRB - 2025 Year 12 Month 17 Day Anticipated trial start date - 2025 Year 12 Month 18 Day Last follow-up date - 2026 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068746

Disclaimer: Curated by HT Syndication.