A multi-centric, non-randomized, post-marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ® as a nasal pack after nasal surgery in pediatric age group (5 to 17 years).
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- The primary endpoint will be achieved if the following criteria are met:
研究概览
简要总结
VELNEZ nasal pack, manufactured and marketed by Datt Mediproducts Private Limited, offers a novel solution as a biodegradable composite nasal dressing. It fragments naturally within a few days of application (3-5 days), obviating the need for painful removal. VELNEZ is designed to provide effective hemostasis, reduce fibrosis, and promote healing while minimizing patient discomfort. By eliminating the risks associated with traditional nasal packing methods, VELNEZ holds significant promise as a safer and more tolerable alternative for pediatric patients.
The rationale for this multi-centric, non-randomized post-marketing surveillance study is to evaluate the safety and tolerability of VELNEZ in pediatric patients (aged 5 to 17 years) undergoing nasal surgery. The study will assess its efficacy in ceasing reactive and secondary bleeding, its non-adhesive properties, and its overall safety profile based on adverse event reporting. Additionally, the study aims to evaluate patient-reported outcomes such as pain levels using, Visual Analog Scale, Breathing effect by Nasal Obstruction Symptom Evaluation (NOSE Score ) And an Endoscopy examination throughout the Study.
Through this study, we aim to generate robust post-marketing data that will further validate the clinical benefits of VELNEZ in this vulnerable population, ensuring its safe and effective use in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject eligible for the use of VELNEZ as a nasal pack in routine clinical practice after planned nasal surgeries such as septoplasty, turbinoplasty, polyp and other nasal surgery.
- •Male and female children in the age group of 5 to 17 years.
- •(Both Included)
- •Subjects whose parents or legally authorized representatives (LAR) can provide written informed consent and, where applicable, subjects who can provide assent in accordance with regulatory requirements.
- •Subjects whose parents or legally authorized representatives (LAR) are willing to allow the collection of their child’s study data at predefined follow-up periods.
排除标准
- •Subjects who are unable to be treated with VELNEZ as a nasal packing in routine clinical practice following planned surgery.
- •Subjects whose parents or legally authorized representatives (LAR) cannot provide written informed consent, or subjects unable to provide assent where applicable.
- •Subjects testing positive for HIV, HBsAg, or HCV.
- •Subjects unwilling or unable to comply with the necessary postoperative visits for data collection.
- •Subjects with an active infection at the surgical site.
- •Subjects with a history of unstable asthma.
- •Subjects currently on aspirin or antiplatelet therapy, or those with bleeding disorders.
- •Hypertensive subjects.
- •Subjects with a history of allergic (hypersensitivity) reactions to any ingredients of the device (VELNEZ) such as Chitosan, Gelatin, or Psyllium husk.
- •Subjects with any medical condition that, in the opinion of the investigator, would make them unsuitable for inclusion (e.g., chronic, relapsing, or hereditary diseases that may interfere with the study outcomes).
- •Subjects with severe rhinosinusitis involving all paranasal sinuses, associated with Sinonasal polyposis, Allergic fungal rhinosinusitis, Gross septal deviation or spurs impinging on the ostiomeatal complex (OMC),Large concha bullosa, or Allergic turbinate hypertrophy in contact with the septum.
- •Subjects with a history of postoperative recurrent rhinosinusitis or bleeding diathesis.
结局指标
主要结局
The primary endpoint will be achieved if the following criteria are met:
时间窗: 60±5 days from device application
1. Study participants achieve complete cessation of reactive and secondary bleeding within 20 minutes post-application of VELNEZ.
时间窗: 60±5 days from device application
2. Study participants tolerate the use of VELNEZ as a nasal pack, with no significant safety concerns reported during the study.
时间窗: 60±5 days from device application
次要结局
- 1. Absence of post-operative adhesions at the surgical site following the use of VELNEZ.(2. Effectiveness of VELNEZ in promoting coagulation as assessed through clinical observation.)
研究者
Dr Akhil Pratap Singh
S.N Medical College, Agra