Post Market Clinical Follow-Up Study on Medical Devices KalobaNaso Useful for Cold and Rhinitis in Adults and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Resolution of the symptoms of nasal congestion
研究概览
简要总结
The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaNaso (a nasal spray) in children, adolescents and adults with common cold symptoms, such as runny nose, nasal congestion and rhinitis. The main questions it aims to answer are:
- Is the product effective in the treatment of common cold symptoms?
- Is the product safe?
After buying the product, participants will be asked to fill in a questionnaire, in order to:
- Assess the cold symptoms before the use of the nasal spray.
- Assess the resolution of cold symptoms after the use of the nasal spray.
- Describe the adverse effect(s)/problem(s) observed while using the product (if any).
详细描述
The Medical Device Regulation (EU) 2017/745 (MDR) considers post-market clinical follow-up (PMCF) as a continuous process that aims to update the clinical evaluation and validate or reassess the benefit-risk balance of the medical device. The PMCF is an integral part of the manufacturer's post-market surveillance plan (PMS).
The medical device in question is CE marked since 2016, with no substantial modification.
The objectives of this Post Market Clinical Follow Up (PMCF) study are: verify the use of this device in a real situation, verify if its efficacy and safety of use are aligned with the provisions of the clinical evaluation; confirm or reassess the benefit/risk balance; update the risk analysis; identify any need for CAPA.
Specific product questionnaires have been developed based on the validated I-NOSE questionnaire, which aim to investigate aspects of Real-World Evidence on efficacy, safety, even in specific categories or situations, known and unknown adverse events, difficulties in use or completeness and clarity of IFUs.
Given the low-risk class of the device (class I - Dir.93/42/EEC), which is intended for use by lay people and normally sold in pharmacies / para-pharmacies, the sponsor planned to distribute the questionnaires to users that have purchased the product through health professionals (pharmacists), who are normally in charge of the distribution of the product.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Resolution of the symptoms of nasal congestion
时间窗: Before use and at the resolution (after maximum 7 days)
A 6-items close question questionnaire developed based on I-NOSE (Italian-Nose Obstruction Symptom Evaluation), a validated and published questionnaire. It is a five-points scale with values from 0 to 4 (0= not a problem; 4 = severe problem)
次要结局
- Rate of known and unknown side-effects and / or other risks associated to the use of medical device(During and after use (from the first application to after maximum 7 days))