NL-OMON51654
已完成
不适用
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD - The RheSolve Study
GALA therapeutics0 个研究点目标入组 15 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- GALA therapeutics
- 入组人数
- 15
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patient is at least 35 years of age.
- •2\. Patient has chronic bronchitis, defined as productive cough for three months
- •in each of two successive years, whereas other causes of productive cough have
- •been ruled out.
- •3\. Patient has a CAT score \>\= 10\.
- •4\. Patient has an SGRQ score \>\= 25\.
- •5\. Patient\*s responses to the first two questions of the CAT instrument sum to
- •\>\= 7 points or the sum is 6 points and the patient\*s total CAT score is \> 20
- •6\. Patient has FEV1/FVC \< 0\.7\.
- •7\. Patient has a pre\-procedure post\-bronchodilator FEV1 percent predicted of \>\=
排除标准
- •1\. Patient has known unresolved lower respiratory tract infection (e.g.,
- •pneumonia, mycobacterium avium\-intracellulare infection (MAI), fungus,
- •tuberculosis).
- •2\. Patient has a steroid\-dependent condition requiring \>10 mg of oral
- •corticosteroid per day.
- •3\. Patient has any implantable electronic device (e.g., pacemaker, cardioverter
- •defibrillator, neuro\-stimulation devices).
- •4\. Patient has a history of arrhythmia within past two years which includes
- •tachy\-atrial arrhythmias, any ventricular tachy\-arrhythmias, or sinus
- •bradycardia with heart rate less than 45 beats per minute.
结局指标
主要结局
未指定
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