A prospective, open-label, multi-center, post market clinical follow-up study to evaluate the safety and performance of MyNasal (TM) Internal Nasal Pre-cut Splints.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 5
- 主要终点
- 1. Pain score
研究概览
简要总结
**Study Name:**A prospective, open-label, multi-center, post market clinical follow-up study to evaluate the safety and performance of MyNasal™ Internal Nasal Pre-cut Splints.
Protocol ID, Version & Date: MMI/ MyNasal Internal Nasal Pre-cut Splints, V3.0.1 dated 08-Jul-2025
Study Device: MyNasal™ Internal Nasal Pre-cut Splints
Indication: The MyNasal™ Internal Nasal Pre-cut Splints are indicated to be used to support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures and facilitate drainage of nasal secretions.
Objective: The aim of the study is to evaluate the safety and performance of MyNasal™ Internal Nasal Pre-cut Splints.
Study Design: A prospective, open-label, multi-center, post market clinical follow-up study .
Rationale:
Nasal septal surgery is one of the most frequently performed procedures in otorhinolaryngology, often conducted either on its own or in combination with other surgeries. Nasal packing is widely regarded as one of the most effective methods for providing septal support and preventing adhesions following nasal surgery. It is commonly used in various endonasal procedures, such as septoplasty, turbinectomy, and sinus surgeries, to prevent complications like synechiae and hematoma. Nasal packing materials serve multiple purposes, including supporting the alignment of septal flaps and closing spaces between cartilage and subperichondrial flaps. Postoperatively, different types of nasal packing are utilized, including medicated or non-medicated gauzes, Telfa, foam, absorbable gelatin sponges, merocel, silicone nasal splints, and polyethylene oxide gel. These risks can be minimized by employing nasal splints and selecting the most suitable packing materials. Internal nasal splints are designed to provide structural support and minimize postoperative complications, addressing the limitations of traditional nasal packing materials like merocel and gauze, which can cause discomfort and mucosal injury. The aim of study to evaluate the safety and performance of the MyNasal™ Internal Nasal Splint Pre-Cut in clinical practice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects across different age groups who require postsurgical splinting of the nasal septum and treated with MyNasal™ Internal Nasal Pre-cut Splints.
- •2.The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent Form.
- •3.When a Subject and LAR (Legally acceptable representative) are illiterate, a literate impartial witness is required during consenting.
- •4.If the Subject is not able to write on behalf of the Subject, the Subject`s LAR (Legally acceptable representative) can fill out the informed consent.
- •5.The Subject should be able to comply with protocol requirements and assessments.
- •6.Subjects requiring short-term post-surgical splinting of the nasal septum after procedure such as septoplasty, rhinoplasty, turbinate reduction, functional or cosmetic surgeries that necessitate internal nasal pre-cut splints 7.Subjects with conditions required nasal stabilization to prevent septal hematoma or adhesion formation post surgery.
- •8.Subjects with normal healing capacity and without contraindications to nasal surgeries.
排除标准
- •Without informed consent, the Subject is not eligible for the study.
- •Any sign of infection at the time of operation.
- •Previous history of any type of nasal surgery.
- •Any known hypersensitivity or allergic reaction to silicone or similar materials.
- •Subjects with severe nasal deformities or obstructions that make placement of the splint unfeasible.
- •Subjects with bleeding disorders that affect wound healing or increase surgical risks.
- •Women who are pregnant or breastfeeding.
- •Subjects with a known or suspected Cerebrospinal Fluid leak, as this condition may complicate the use of nasal pre-cut splints and increase the risk of postoperative complications such as infection.
结局指标
主要结局
1. Pain score
时间窗: 1.Time Frame: Pre and Post-operative, 7 days ± 2 days, 15 days ± 2 days, 1-month ± 7 days follow-up and 3-month ± 15 day follow-up | 2.Time frame: Pre-operative and Post-operative
2. Nasal Airway patency
时间窗: 1.Time Frame: Pre and Post-operative, 7 days ± 2 days, 15 days ± 2 days, 1-month ± 7 days follow-up and 3-month ± 15 day follow-up | 2.Time frame: Pre-operative and Post-operative
次要结局
- 1. Total Operative time(2. Quality of life)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd