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 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subject eligible to use VELNEZ as a nasal pack in routine clinical practice after planned
•surgery (either for septoplasty or 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-up periods.

•1. Subject who unable to treat with the VELNEZ as a nasal packing in routine clinical practice
•after planned surgery.
•2. Subject who cannot provide written informed consent for data collection.
•3. Subject 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. Subject with a history of asthma
•6. Subject 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. Subject with 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. Subject with a history of postoperative recurrent rhino sinusitis and subjects with
•bleeding diathesis.

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