NL-OMON55012已完成不适用
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- •1. Diagnosis of COPD
- •2. >= 40 years of age
- •3. FEV1/FVC <= 70%
- •4. Post-bronchodilator FEV1 <= 45% of predicted
- •5. Total Lung Capacity > 100% of predicted
- •6. Residual Volume (RV) > 175% of predicted
- •7. RV/TLC > 55%
- •8. Marked dyspnea defined by a score of >= 2 on mMRC dyspnea scale of 0-4
- •9. Emphysema with >= 20% destruction (-950HU) of one or more lobe(s)
- •10. Stopped smoking for >= 6 months prior to entering the study
- •11. Completed a pulmonary rehabilitation program prior to entering the study
- •and/or have regular (at least once a week) physiotherapy
- •12. Ability to read, understand and sign the informed consent form
排除标准
- •1. History of recurrent clinically significant respiratory infections and/or
- •COPD exacerbations, defined as >= 2 hospitalizations for respiratory infections
- •and/or COPD exacerbations during the year prior to enrolment
- •2. History of recurrent clinically significant respiratory infections and/or
- •COPD exacerbations, defined as >= 3 courses of prednisolone and/or antibiotics
- •for respiratory infections and/or COPD exacerbations during the year prior to
- •3. Clinically significant bronchiectasis
- •4. Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg)
- •and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
- •5. >= 10 mg prednisone (or equivalent dose of other corticosteroids) daily
- •6. Inability to walk > 140 meters in 6 minutes
- •7. Known pulmonary hypertension defined by right ventricular systolic pressure
- •> 45 mmHg and/or evidence of pulmonary hypertension or right ventricular
- •failure on echocardiogram
- •8. Significant paraseptal emphysema
- •9. Giant bullae (>1/3 of lung volume)
- •10. Medical history of asthma
- •11. Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
- •12. Underwent previous treatment with thermal vapor ablation, AeriSeal,
- •Cryospray, endobronchial coils or endobronchial valves (if still implanted)
- •13. Evidence of other disease(s) that have a predicted survival of less than
- •14. Inability to tolerate bronchoscopy under general anaesthesia
- •15. Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy
- •(such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be
- •permanently stopped prior to entering the study
- •16. Pregnant, lactating or plans to become pregnant within the study timeframe
- •17. Known sensitivity to drugs required to perform bronchoscopy under general
- •anaesthesia
- •18. Any other disease(s), condition(s) or habit(s) that would interfere with
- •completion of study and follow up assessments, would increase the risks of
- •bronchoscopy or assessments or in the judgment of the investigator would
- •potentially interfere with the treatment
- •19. Known Nickel, Titanium, or Nitinol allergy
研究者
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