Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Wet Weight of Sputum Produced
研究概览
简要总结
The aim of this study is to assess the effectiveness of an Airway Clearance System.
详细描述
The study will compare the effectiveness of The Monarch™ System and The Vest® Airway Clearance System. All subjects will receive treatment with both systems and endpoints will be compared.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Cystic Fibrosis (CF) (by sweat test and/or genetics)
- •Age ≥ 15 years
- •Ability to expectorate sputum daily - determined by treating physician
- •Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit 1
- •Patient who requires regular home airway clearance therapy
排除标准
- •Forced Expiratory Volume in 1 Second (FEV1) < 30 % predicted or > 90 % predicted
- •Anticipated requirement for hospitalization within the next three weeks
- •History of pneumothorax within the past 6 months prior Visit 1
- •History of haemoptysis requiring embolization within the past 12 months prior to Visit 1
- •Inability to perform Monarch™ and/or Vest® System therapy as directed
- •Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
- •Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1
- •Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA)
- •Pregnant or lactating female
- •Has a pacemaker or implantable cardioverter defribillator (ICD)
研究组 & 干预措施
Study Group
Study subjects will serve as their own control and all will receive treatment with two different Airway Clearance Systems- the Vest® Airway Clearance System and the Monarch™ System. Subjects will be randomized to which treatment is received first.
干预措施: Vest® Airway Clearance System (Device)
Study Group
Study subjects will serve as their own control and all will receive treatment with two different Airway Clearance Systems- the Vest® Airway Clearance System and the Monarch™ System. Subjects will be randomized to which treatment is received first.
干预措施: Monarch™ System (Device)
结局指标
主要结局
Wet Weight of Sputum Produced
时间窗: Through study completion, an average of 2 months
Assessment of the wet weight of total sputum that is produced as a result of each of two therapy sessions. The total wet weight includes the wet weight of sputum collected each 30-minute therapy session + the wet weight of sputum collected during a 1-hour collection period following each therapy.
次要结局
- Sputum Volume(Through study completion, an average of 2 months)
- Functional Respiratory Imaging(Through study completion, an average of 2 months)
- Brody Scores (Scoring of CT Scans)(Through study completion, an average of 2 months)
- Lung Clearance Index(Through study completion, an average of 2 months)
- Subjective satisfaction surveys(Through study completion, an average of 2 months)
- Spirometry(Through study completion, an average of 2 months)