NL-OMON42706已完成不适用
A Prospective Safety and Feasibility Study of the RejuvenAir* System Metered Cryospray Therapy for Chronic Bronchitis Patients. - Safety and Feasibility Study of RejuvenAir* for Treating Chronic Bronchitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Males and females >=40 to <=75 years of age.
- •Subject is able to read, understand, and sign a written Informed Consent.
- •Subject agrees to continue maintenance pulmonary/COPD medications for the
- •duration of the study.
- •Diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease
- •(COPD) for a minimum of two years. (Chronic Bronchitis is defined clinically as
- •chronic productive cough for 3 months in each of 2 successive years in a patient in
- •whom other causes of productive cough have been excluded.)
- •Pre-procedure post bronchodilator FEV1 of greater than or equal to 30% and less
- •than or equal to 80% of predicted within 3 months of enrollment.
- •Smoking history of at least 10 pack years.
- •Non-smoking for a minimum of 6 months prior to consent and agrees to continue
- •not smoking for the duration of the study.
- •Subject is able to adhere to and undergo 3 (4 if in Phase A) bronchoscope
- •procedures that includes lung biopsies and multiple MCS treatments in the
- •opinion of the investigator or per hospital guidelines. (Only Phase A subjects
- •receive biopsies)
排除标准
- •Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks
- •of study bronchoscopy.
- •Subject has had a CB and/or COPD exacerbation (requiring steroids and/or
- •antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their
- •treating physician
- •Subject has clinically significant bronchiectasis or other respiratory disease other
- •than chronic bronchitis and COPD.
- •Diagnosis of asthma with an onset before 30 years of age
- •Subject has bullous emphysema characterized as large bullae >30 millimeters on
- •Subject has had a transplant.
- •Subject has the inability to walk >140 meters
- •Subject has PaC02 >8kPa, or a PaO2<7kPa at room air.
- •Subject has a RVSP >45mmHg or a LVEF<45% on 2D-cardiac echo.
- •Subject has undergone lung surgery: pneumonectomy, lobectomy, bullectomy,
- •lung volume reduction surgery
- •Subject has had a prior lung device procedure, including emphysema stent(s)
- •implanted, lung coils, valves, lung denervation or other devices for emphysema.
- •Subject is unable to temporarily discontinue use of anticoagulant therapy:
- •warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
- •Subject is on >10 mg of prednisolone/day.
- •Subject has a serious medical condition, such as: uncontrolled congestive heart
- •failure, uncontrolled angina, myocardial infarction in the past year, renal failure,
- •liver disease, cerebrovascular accident within the past 6 months, uncontrolled
- •diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux
- •Subject is pregnant, nursing, or planning to get pregnant during study duration.
- •Subject has received chemotherapy within the past 6 months or is expected to
- •receive chemotherapy during participation in this study.
- •Subject is or has been in another clinical investigational study within 6 weeks of
- •Subject has known sensitivity to medication required to perform bronchoscopy
- •(such as lidocaine, atropine, and benzodiazepines).
- •Subject has been in another clinical investigational study within 6 weeks of
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