JPRN-jRCTs032190120已完成1 期
Data collection about the flu follicle
Fukuda Jun0 个研究点目标入组 9,047 人开始时间: 2019年10月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9,047
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
研究者
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