Data collection about the flu follicle
- Conditions
- Suspicion of the flu
- Registration Number
- JPRN-jRCTs032190120
- Lead Sponsor
- Fukuda Jun
- Brief Summary
Considering frequencies and degrees of AEs, this device will generally be able to use safe if users follow the device's procedures or manuals and understand having possibility of AEs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9047
(1) A person who obtains written consent based on the voluntary intention of the person or his/her proxy (parent).
(2) A person who is 6 years old or older at the enrollment.(age when tongue depressor which is a part of medical equipment components under development can be used).
For pediatric person, an investigator carefully should decide the eligibility of the person for the study, taking into account the physical size and the understanding of the person for the study.
(3) A person with one or more of the following 4 items (for (i) to (iii), excluding a person who continue for more than a week).
i) Fever over 37 degree C.(including cases at 37 degree C or more at home or anywhere).
ii) Joint pain,muscle pain, headache, systemic symptoms,(ex. General malaise, loss of appetite, etc.) etc.
iii) Respiratory symptoms with coughing, pharyngeal pain or nasal discharge/congestion.
iv) The flu is suspected by investigator judgment such as close contact with the flu patients.
(1) A person with mobile tooth
(2) A person with severe lesions in the oral cavity where clinical research equipment comes into contact.
(3) A person with severe nausea and is judged by investigator as inappropriate to use the equipment.
(4) A person with difficulty photographing aperture position by the equipment (ex. the physical size is small and the equipment cannot be inserted into the oral cavity, difficulty maintaining the open position due to pain such as temporomandibular disorders or poor compatibility of dentures, etc.)
(5) A participants in other clinical study within 7 days prior to the use of the equipment, a person will participate in other study (except Post-marketing survey) from the date of the consent to the end of the study period, a person who cannot follow the protocol procedure (ex. mental, family, social or geographical reasons, etc.).
(6) A pediatric person who has a clearly insufficient understanding for the study. Also, the person who is small physical size and unable to insert the equipment into the oral cavity.
(7) A person who is decided by a principal investigator (or Sub-investigator) as ineligible subject for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot Applicable
- Secondary Outcome Measures
Name Time Method ot Applicable