Surgical Reduction of the Inferior Turbinate Using a Coblation® Device for Treatment of Nasal Obstruction: A Prospective, Multi-center Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire.
研究概览
简要总结
The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms.
详细描述
Chronic rhinitis, or inflammation of the nasal mucosa, is one of the most common causes of nasal obstruction in the pediatric population. Chronic rhinitis may result in mucous gland hypertrophy, engorgement of the vascular system and deposition of collagen in the nasal mucosa. These changes occur most prominently in the inferior turbinate, causing enlargement and nasal obstruction. In children, inferior turbinate hypertrophy is associated with a greater degree of nasal obstruction relative to adults because of their small nasal anatomy.
Cases that do not respond to conservative treatments may be considered for one of many surgical procedures, including turbinate excision, submucosal resection, submucosal cautery, laser treatment, cryosurgery, powered microdebridement, or radiofrequency-based ablation. Clinical studies have shown that bipolar radiofrequency-based plasma (Coblation®) devices are capable of creating focal submucosal lesions with minimal or no damage to structures adjacent to the treated area. At present, however, this technique has not been formally evaluated in children. This study will investigate whether surgical turbinate reduction performed using a Coblation device is associated with reduced nasal obstruction symptoms that has failed to improve with other treatment methodologies.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is >=6 and <=17 years old.
- •Patient has had symptoms of nasal obstruction for >=6 months.
- •Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
- •Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
- •Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
- •Patient (or guardian) must sign IRB approved informed consent form.
排除标准
- •Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:
- •Septal deviation
- •Concha bullosa
- •Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)
- •Nasal polyps
- •Nasal valve collapse.
- •Patient has been diagnosed with obstructive sleep apnea not originating from the turbinates.
- •Patient has active or chronic upper airway infection that may contribute to nasal obstruction (not including chronic rhinosinusitis).
- •Patient has active coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery).
- •Patient has systemic disease affecting the nasal passage(e.g. Wegener's granulomatosis).
- •Patient is receiving or has received immunotherapy (any type) within 12 months of enrollment.
- •Patient has a nasal septal perforation.
- •Patient has had any previous turbinate surgery.
- •Patient has had any previous nasal surgery.
- •Patient has had any sinus surgery within 6 months of enrollment.
- •Patient has had an adenoidectomy within 3 months of enrollment.
- •Patient is pregnant or potentially pregnant.
- •Patient or caregiver is incapable of understanding or responding to the study questionnaires.
- •Patient is participating in another clinical study during the 12 month enrollment period.
结局指标
主要结局
Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire.
时间窗: 6 weeks, 6 months, 12 months
次要结局
- Morbidity by determining the frequency, type, and severity of any observed adverse events through 12 months following surgical treatment.(Through 12 months)
- To assess durability of treatment using: a. Self-reported obstructive symptoms measures b. Physical examination measures, d. Blinded evaluation of anterior rhinoscopy images(6 weeks, 6 months, 12 months)