Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline
研究概览
简要总结
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 19 or greater
- •Diagnosis of Chronic Rhinosinusitis (CRS)
- •Failure of appropriate medical management
- •Radiographic evidence of inflammation of the paranasal sinuses
- •Surgical candidate
- •Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures
- •Able to read and understand English
排除标准
- •Not suitable for balloon dilation for all peripheral sinuses that require treatment
- •Clinically significant illness that may interfere with the evaluation of the study
- •Patients involved in other clinical studies 30 days prior to study
- •Pregnant or lactating females
- •Patients unable to adhere to follow-up schedule or protocol requirements
研究组 & 干预措施
Balloon Sinus Dilation
Subjects with chronic sinusitis electing to have a balloon sinus dilation
干预措施: Balloon sinus dilation (Device)
Medical Management
Subjects with chronic sinusitis electing to continue with medical therapy
干预措施: Medical Management (Drug)
结局指标
主要结局
Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline
时间窗: 24 weeks post treatment
The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best). The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.
次要结局
- Change in Disease-specific Medication Usage(12, 24 and 52 weeks post treatment)
- Number of Sinus Infections(24 and 52 weeks)
- Post-operative Return to Normal Activity (RTNA)(2 weeks post treatment)
- Change in SNOT-20(12 weeks, 24 weeks, 52 weeks post treatment)
- Missed Days Work/School(12, 24 and 52 weeks post treatment)
- Number of Sinus-related Medical Care Visits(12 weeks, 24 weeks, 52 weeks post treatment)
- Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline(12, 24, and 52 weeks post treatment)
- Change in RSDI(12, 24 and 52 weeks post treatment)
- Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure(52 weeks)
- Number of Subjects Requiring Revision for Subjects Electing BSD(52 weeks)