A Prospective, Multi-center, Post-Market Clinical Study to Evaluate the Safety and Effectiveness of the REFLEX ULTRA 45 for the Coblation Inferior Turbinate Reduction in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months
研究概览
简要总结
The study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China. The study product is REFLEX ULTRA 45 (EIC4845-01/EICA4845-01). Also it needs to be performed with the controller system COBLATOR II or WEREWOLF. The sample size is 105 subjects with approximate 6 sites in China mainland.
详细描述
Inferior turbinate hypertrophy (ITH) is a common condition characterized by the enlargement of the inferior turbinate which is mainly due to swelling of the sub-mucosa and rarely due to enlargement of the bone itself. Based on current studies, there are several surgical techniques is being widely used in clinic for ITH includes turbinectomy, electrocautery, laser surgery, cryotherapy, Microdebrider-assisted inferior turbinoplasty (MAIT) and radiofrequency ablation (RFA). The technique used in this study for ITH is Coblation produced by REFLEX ULTRA 45. With limited high quality literature in Chinese population, it is the main purpose to generate high quality evidence among the Chinese population to establish the effectiveness and safety in Chinese population with sufficient outcomes evaluation and appropriate inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with at least two-year history of perennial rhinitis and who has failed one month of continuous standardized treatment with hormonal nasal spray by the date of surgery.
- •Subject with nasal obstruction due to turbinate hypertrophy and is suitable to receive coblation inferior turbinate reduction for bilateral nasal cavity without outfracture of inferior turbinate per the investigator's judgement.
- •Subject is 18 - 65 years old (inclusive).
- •Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) approved consent form before any study procedures are performed, including pre- operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
- •Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
排除标准
- •Subject who does not meet the indication or is contraindicated according to specific REFLEX ULTRA 45 's Instructions for Use (IFUs).
- •Subject with obvious deviation of nasal septum with the necessity of surgery under investigator's judgement.
- •Participation in the treatment period of another clinical trial within thirty (30) days of all visits completed.
- •Subject who needs other nasal surgery other than single inferior turbinate reduction evaluated by MRI and nasal endoscopy.
- •Subject who has nasal obstruction due to inferior turbinate bony hypertrophy.
- •Subject who was treated with inferior turbinate reduction before informed consent.
- •Subjects who completed the Zung Self-Rating Anxiety Scale and the anxiety rate is more than
- •Woman who is pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- •Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.
- •Subject who has participated previously in this clinical trial or who has been withdrawn.
- •Subject with a history of poor compliance with medical treatment.
- •Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
结局指标
主要结局
Nasal Obstruction Symptom Evaluation (NOSE) score at 3 Months
时间窗: 3 months
Nasal Obstruction Symptom Evaluation (NOSE) consists of 5 questions regarding nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through nose, trouble sleeping, and ability to get enough air through nose during exercise or exertion. NOSE scores range from 0 to 100, with a higher score indicating a severe problem (i.e., worse outcome) and lower score indicating no problem (i.e., better outcome).
次要结局
- Nasal Obstruction Symptom Evaluation (NOSE) score(7 days, 1 month, 6 months, 1 year, 2 years)
- 36-Item Short Form Survey (SF-36)(7 days, 3 months, 1 year, 2 years)
- Unilateral Nasal Resistance(3 months, 1 year, 2 years)
- Total Nasal Resistance(3 months, 1 year, 2 years)
- Minimal Cross-Sectional Area(3 months, 1 year, 2 years)
- Nasal Volume(3 months, 1 year, 2 years)
- Mucociliary Transport Function Time(3 months, 1 year, 2 years)
- Mucociliary Transport Function Distance(3 months, 1 year, 2 years)
- Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Anterior Rhinoscopy(7 days)
- Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Presence of Crusting and Bleeding by Anterior Rhinoscopy(7 days)
- Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Inferior Turbinate Hypertrophy Grade by Nasal Endoscopic Assessment(3 months, 1 year, 2 years)
- Surgeon Evaluation of Turbinate/Mucosal Tissue Health - Magnetic Resonance Imaging (MRI)(3 months, 1 year, 2 years)
- Duration of Surgery(During procedure)
- Intraoperative Bleeding(During procedure)