MyNasal Internal Nasal Bi-Valve Splints-A prospective, multi-center, observational, real world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal(TM) Internal Nasal Bi-valve Splints
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 5
- 主要终点
- 1.Nasal airway patency
研究概览
简要总结
**Title:**A prospective, multi-centers, observational, real-world, clinical investigational study to evaluate the safety and performance of MyNasal™ Internal Nasal Bivalve Splints. Short Title MyNasal Internal Nasal Bi-valve Splints
Protocol ID, Version & Date: MMI/MyNasal Internal Nasal Bi-valve Splints Version 2.0.0_03-Feb-2025
**Study device :**MyNasal™ Internal Nasal Bi-valve Splints Indication Internal Nasal Bi-Valve splints are indicated to provide vital septal support and prevent adhesions between the septum and lateral nasal wall. Objective The objective of this study is to evaluate the safety and performance of MyNasal Internal Nasal™ Bi-valve Splint in nasal surgeries or procedures to provide vital septal support and prevent adhesions between the septum and lateral nasal wall.
Study Design: A prospective, multi-centers, observational, real-world, clinical investigational study.
Rationale of the Study :The study aims to evaluate the use of nasal splints is a standard practice in nasal surgeries or procedures to support and stabilize the nasal passages during the healing process. These devices are critical in maintaining structural integrity, minimizing complications, and improving patient outcomes. However, the safety and performance of specific devices in real-world settings require rigorous evaluation to ensure their efficacy and tolerability across diverse patient populations. The MyNasal™ Internal Nasal Bi-valve Splints are designed to use nasal surgeries or procedures to support and stabilize the nasal passages during the healing process. This study aims to evaluate the safety and performance of MyNasal Internal Nasal Bi-valve Splints in real-world clinical settings
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
- •Subject scheduled for nasal surgery (septoplasty, rhinoplasty, etc.) requiring internal nasal support shall be included.
- •Subjects across different age groups who require post-surgical splinting of the nasal septum and would be treated with MyNasal Internal Nasal Bi-valve Splints.
- •Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
- •Subject is willing and able to comply with post-operative scheduled clinical evaluations shall be included.
- •Subject for whom the treating surgeon deems that internal nasal splints are required to maintain nasal patency and prevent septal hematoma, adhesion formation, or collapse post-surgery shall be included.
排除标准
- •Subject any known sensitivity or allergy to silicone or any material used in the splint will disqualify a participant from the trial shall be excluded.
- •Subjects with active nasal infections or untreated chronic sinusitis shall be excluded.
- •Subjects with coagulopathy or bleeding disorders, or those taking anticoagulant or antiplatelet treatment that may affect with clot formation and wound healing will be excluded shall be excluded.
- •Subject presents with recent or acute nasal trauma or fractures that necessitate more sophisticated surgical treatments than the splints are insufficient to support the healing and will be excluded shall be excluded.
- •Subjects who have undergone previous nasal surgeries involving the insertion of permanent devices may have difficulty with bi- valve splints.
- •These splints may be difficult to insert or remove due to the presence of such device and shall be excluded.
- •Pregnant women will be excluded.
结局指标
主要结局
1.Nasal airway patency
时间窗: 1. Time frame: Pre-operative and postoperative | 2. Time frame: Post-operative, 7 days ± 2 days, 15 days ± 2 days | 3. Time frame: Pre-operative, Postoperative
2. Structural Support and Stability
时间窗: 1. Time frame: Pre-operative and postoperative | 2. Time frame: Post-operative, 7 days ± 2 days, 15 days ± 2 days | 3. Time frame: Pre-operative, Postoperative
3. Bleeding and hematoma
时间窗: 1. Time frame: Pre-operative and postoperative | 2. Time frame: Post-operative, 7 days ± 2 days, 15 days ± 2 days | 3. Time frame: Pre-operative, Postoperative
次要结局
- 1. Hematoma formation(2. Adhesion formation)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd