Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 主要终点
- Mean Intra-patient Change in SNOT-20 Score
研究概览
简要总结
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female, 18 year or older
- •Diagnosis of Chronic Rhinosinusitis
- •Planned Endoscopic Sinus surgery
排除标准
- •Cystic Fibrosis
- •Severe Polyposis
- •Sinonasal tumors
- •History of facial trauma precluding access to sinus ostium
- •Ciliary Disfunction
- •Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
- •Pregnant or lactating female
- •Inability to tolerate an awake procedure
- •Participation in another investigational clinical study involving treatment for chronic rhinosinusitis
结局指标
主要结局
Mean Intra-patient Change in SNOT-20 Score
时间窗: Baseline and 24 weeks
Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
Mean Intra-patient Change in Lund-Mackay CT Scan Score
时间窗: Baseline and 24 weeks
Change in Lund-Mackay CT score for paired baseline and 24 week data. The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.
次要结局
- Procedure Tolerability(Day 0 (Day of Procedure))
- Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary(Day 0 (Day of Procedure))
- Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.(Day 0 (Day of Procedure))
- Mean Number of Days to Return to Normal Activities(2 weeks)