An observational, open label, single centre, post marketing surveillance study to evaluate safety and tolerability of VELNEZ with other marketed products as nasal pack used in nasal surgery

Datt Mediproducts Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Age in between 18-60 years.
•2.The subject has a planned nasal surgery (either for septoplasty with or without FESS or turbinoplasty).
•3.Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.
•4.The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

•1.Subjects with medical emergency, where treatment is more essential than the informed consent process and he or his representative deny to participate in study.
•2.Subjects who cannot provide informed consent such as unconscious subjects.
•3.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
•4.Subjects with severe rhinosinusitis involving all the paranasal sinuses associated with sinonasal polyposis, allergic fungal rhinosinusitis, gross septal deviation or spurs hitching on the ostiomeatal complex (OMC) region huge concha bullosa or allergic turbinate hypertrophy in contact with septum.
•5.Subject has an active infection at the planned surgery site.
•6.Subjects who have a history of previous septoplasty, allergy and/or asthma
•7.Postoperative recurrent rhino sinusitis, patients with bleeding diathesis,
•8.Subject on aspirin or anti-platelet drugs therapy.
•9.hypertensive patients
•10.Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e Chitosan, Gelatin etc

发起方