CTRI/2024/06/068328已完成Unknown
A post marketing clinical follow-up study (PMCF) to evaluate safety and tolerability of VELNEZ as a nasal pack after nasal surgery.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Study participants who achieve complete hemostasis within 10 minutes of
研究概览
简要总结
VELNEZ is a sponge-based biodegradable composite dressing that naturally breaks down within days of application, eliminating the need for removal procedures and reducing associated pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject eligible for use of VELNEZ as a nasal pack post- nasal surgery.
- •Male and female in an age group of 18 to 80 years, both included.
- •Subjects who can provide written informed consent for participation in the study.
- •Subjects who allow their data to be collected for the study at predefined follow-up periods.
排除标准
- •1.Subject who are unable to be treated with VELNEZ as a nasal packing post-surgery.
- •Subject who cannot provide written informed consent for study data collection.
- •Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
- •Subject with an active infection at the site of surgery.
- •Subject with a history of asthma.
- •Subject who are on aspirin/ anti-platelet drugs.
- •Hypertensive subjects.
- •Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device.
- •(i.e Chitosan, Gelatin and Psyllium husk)
- •Subject with bleeding disorders.
- •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).
- •Subjects with severe inflammation of nasal passages/ sinus cavities.
- •Subjects with a history of prospective recurrent rhino sinusitis and subjects with bleeding diathesis.
- •Subject found positive for serology.
- •Subject on immunosuppressive drugs.
结局指标
主要结局
Study participants who achieve complete hemostasis within 10 minutes of
时间窗: 10 minutes of the device application, without any associated adverse events.
device application, without any associated adverse events.
时间窗: 10 minutes of the device application, without any associated adverse events.
次要结局
- Study participants who achieve complete participants within 20 minutes of(device application, without any associated adverse events.)
研究者
Dr Manish Munjal
Sir Ganga Ram Hospital, New Delhi
研究点 (1)
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