A post marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ as a nasal pack after nasal surgery

Datt Mediproducts Pvt Ltd0 个研究点目标入组 37 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.Subject eligible to use VELNEZ as a nasal pack in routine clinical practice after planned surgery (either for septoplasty, turbinoplasty).
•2.Male and female of age group between 18 to 60 years.
•3.Subjects who can provide informed consent form in writing to provide data for the study.
•4.Subjects who allow their data to be collected for the study at predefined follow-upperiods.

•1.Subject whose nasal cavity cannot be packed with the VELNEZ as a nasal pack in routine clinical practice after planned surgery.
•2.Subjects who cannot provide written informed consent for data collection.
•3.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
•4.Subject with an active infection at the planned surgery site.
•5.Subjects who have a history of asthma
•6.Subjects who are on aspirin or anti-platelet drugs therapy.
•7.Hypertensive subjects
•8.Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e Chitosan, Gelatin and Psyllium husk etc.
•9.Subjects who have bleeding disorders.
•10.Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
•11.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.
•12.Subjects who have history of postoperative recurrent rhino sinusitis, subjects with bleeding diathesis.

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