CTRI/2021/09/036437
Completed
Phase 4
A post marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ as nasal pack after nasal surgery.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: J348- Other specified disorders of noseand nasal sinuses
- Sponsor
- Datt Mediproducts Pvt Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •4\. Subjects who allow their data to be collected for the study at predefined follow\-up
Exclusion Criteria
- •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\. 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\. 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
Outcomes
Primary Outcomes
Not specified
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