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).
Overview
- Phase
- Post Marketing Surveillance
- Status
- Recruiting
- Sponsor
- Datt Mediproducts Pvt Ltd
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- The primary endpoint will be achieved if the following criteria are met:
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 17.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
The primary endpoint will be achieved if the following criteria are met:
Time Frame: 60±5 days from device application
1. Study participants achieve complete cessation of reactive and secondary bleeding within 20 minutes post-application of VELNEZ.
Time Frame: 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.
Time Frame: 60±5 days from device application
Secondary Outcomes
- 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.)
Investigators
Dr Akhil Pratap Singh
S.N Medical College, Agra