A prospective, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal(TM) Internal Nasal Airway Splints.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- 1. Nasal obstruction
研究概览
简要总结
Study name: A prospective, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal™ Internal Nasal Airway Splints..
**Protocol Number, Version, and Date:**MMI/MyNasal INA Splints, V3.0.1 dated 08-Jul-2025
Indication: Nasal splints are used to support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures, maintain open airways for better airflow, and facilitate drainage of nasal secretions.
Study Objectives: The objective of this study is to evaluate the safety and performance of MyNasal™ Internal Nasal Airway Splints in Subjects who require post-surgical splinting of the nasal septum in septoplasty and rhinoplasty.
Study Design: A prospective, multi-center, observational, real-world, Post marketing clinical follow-up study.
**Rationale of the Study:**The rationale for conducting a prospective study on MyNasal™ Internal Nasal Airway Splints in real-world settings is to comprehensively evaluate their clinical effectiveness and impact on Subject outcomes outside of controlled environments. This study aims to assess not only the improvement in nasal airflow but also the comfort and compliance of Subjects using these splints, recognizing that experiences may vary in everyday clinical practice. Additionally, the investigation will focus on the safety profile of the splints, identifying any complications or adverse effects that may arise in diverse Subject populations. Furthermore, it will track long-term outcomes to understand the sustained benefits or potential drawbacks of splint usage, providing insights into their role in ongoing nasal health management. Lastly, analyzing resource utilization, including costs and recovery times, will help optimize treatment protocols and enhance overall Subject care in Ear, Nose, and Throat practices.
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
- •Subjects across different age groups who require postsurgical splinting of the nasal septum and treated with MyNasal™ Internal Nasal Airway Splints.
- •Subject who has been provided written informed consent.
- •Subject who agreed to undergo all clinical investigations and follow-up visits as per protocol requirements.
- •Subject scheduled for nasal surgery (septoplasty, rhinoplasty, etc.) requiring internal nasal
- •Subject who required maintaining support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures, maintain open airways for better airflow, and facilitate drainage of nasal secretions.
排除标准
- •Subjects with a history of respiratory tract infection and nasal decongestant use within 1 month before the visit
- •Pregnant or lactating women.
- •Subject with a history of craniocerebral and nasal surgery.
- •Subject any known sensitivity or allergy to silicone or any material used in the splint.
- •Subjects with active nasal infections or untreated chronic sinusitis.
- •Subjects with coagulopathy or bleeding disorders, or those taking anticoagulant or antiplatelet treatment that may affect with clot formation and wound healing.
- •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.
结局指标
主要结局
1. Nasal obstruction
时间窗: 1. Time Frame: Baseline, postoperative, 30 days ± 7 days, 3 months ± 15 days | 2. Time | Frame: Intra-operative, 7 days ± 2 days, 30 days ±7 days, 3 months ± 15 days | 3.Time frame: | post-operative, 7 days ± 2 days, 30 days ± 2 days | 4. Time frame: Pre-operative | and post-operative
2. Complications and AE/SAE related to device
时间窗: 1. Time Frame: Baseline, postoperative, 30 days ± 7 days, 3 months ± 15 days | 2. Time | Frame: Intra-operative, 7 days ± 2 days, 30 days ±7 days, 3 months ± 15 days | 3.Time frame: | post-operative, 7 days ± 2 days, 30 days ± 2 days | 4. Time frame: Pre-operative | and post-operative
3. Structural Support and Stability
时间窗: 1. Time Frame: Baseline, postoperative, 30 days ± 7 days, 3 months ± 15 days | 2. Time | Frame: Intra-operative, 7 days ± 2 days, 30 days ±7 days, 3 months ± 15 days | 3.Time frame: | post-operative, 7 days ± 2 days, 30 days ± 2 days | 4. Time frame: Pre-operative | and post-operative
4. Nasal Airway Patency
时间窗: 1. Time Frame: Baseline, postoperative, 30 days ± 7 days, 3 months ± 15 days | 2. Time | Frame: Intra-operative, 7 days ± 2 days, 30 days ±7 days, 3 months ± 15 days | 3.Time frame: | post-operative, 7 days ± 2 days, 30 days ± 2 days | 4. Time frame: Pre-operative | and post-operative
次要结局
- 1.Pain and discomfort(2. Nasal airflow)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd