RheOx European Post-Market Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Safety: Incidence of SAEs
研究概览
简要总结
Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
详细描述
RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.
Subjects will be required to submit to several tests and questionnaires during the study including respiratory function tests.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has moderate to severe Chronic Bronchitis
排除标准
- •Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device.
- •Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block.
- •Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.
结局指标
主要结局
Safety: Incidence of SAEs
时间窗: Through end of study (24 months post bilateral treatment)
Incidence of serious adverse events associated with RheOx treatment through 24 months
Quality of Life: CAT
时间窗: Through end of study (24 months post bilateral treatment)
COPD Assessment Test (CAT) questionnaire
Quality of Life: SGRQ
时间窗: Through end of study (24 months post-bilateral treatment)
St. George Respiratory Questionnaire
次要结局
- Pulmonary Function: FEV1(Through end of study (24 months post-bilateral treatment))
- Pulmonary Function: FVC(Through end of study (24 months post-bilateral treatment))
- COPD Exacerbations(Through end of study (24 months post-bilateral treatment))