on-interventional Post-Market Clinical Follow-up Study to endorse performance and safety of Weiche Nasensalbe nach Dr. Bader® for moistening the dry nasal mucosa in the anterior area of the nose - BTS1937_22

Hälsa Pharma GmbH0 个研究点目标入组 50 人开始时间: 2023年11月2日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Adult study participants (= 18 years) suffering from a dry nose, (e.g. patients suffering from rhinitis sicca [anterior], allergic rhinitis, or participants predisposed by age or working or living conditions, patients using supportive nasal administration of oxygen, patients suffering from obstructive sleep apnoea, patients after head and neck radiotherapy)
•2.Indication for use of Weiche Nasensalbe nach Dr. Bader® on the anterior part of the nose, according to the IFU and the investigator’s judgement
•3.A nasal dryness” severity of = 3 measured on a VAS scale.
•4.Written informed consent
•5.Willingness, not to use any other prescription and non-prescription medication or medical device for treatment of symptoms of nasal dryness during the Post-Market Clinical Follow-up Study

•1.Any clinically relevant disease or structural defect that might interfere with clinical evaluations or that could affect the outcome of the study
•2.Hypersensitivity or allergy to any of the product ingredients
•3.Patients with injured or freshly operated nasal mucosa
•4.Bedridden patients
•5.Treatment with any kind of rhinological agent or necessity of any concomitant treatment that could affect the outcome of the study (e.g. nasal or systemic corticosteroids, antimicrobials) within the last 7 days
•6.Study participants not able to follow study procedures, e.g. due to language barrier or mental /psychological disorders
•7.Study participants under any clinical investigation in the last 30 days
•8.Subjects not able or willing to sign informed consent.

发起方

Hälsa Pharma GmbH