NCT03886961招募中不适用
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in pepsin levels
研究概览
简要总结
A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
- •13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation
- •Patient must be willing and able to provide informed consent
- •Understands the clinical study requirements and is able to comply with follow-up schedule
排除标准
- •Currently being treated with another investigational medical device and/or drug
- •Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
- •Previous head or neck surgery / radiation
- •Carotid artery disease, thyroid disease, or history of cerebral vascular disease
- •Nasopharyngeal cancer
- •Suspected esophageal cancer
研究组 & 干预措施
Lung Transplant Patients
Experimental
For the first four weeks, lung transplant patients will not wear the Reflux Band. Use of the Reflux Band will subsequently commence in the next four weeks.
干预措施: Reflux Band (Device)
结局指标
主要结局
Change in pepsin levels
时间窗: Baseline; Week 4; Week 8
The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.
Change in amylase levels
时间窗: Baseline; Week 4; Week 8
The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.
次要结局
未报告次要终点
研究者
研究点 (2)
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