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临床试验/NL-OMON38731
NL-OMON38731撤回2 期

A feasibility and safety study of bronchoscopic intrabullous autologous blood instillation for the treatment of severe bullous emphysema. - BIABI study

niversitair Medisch Centrum Groningen0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
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

  • - Age > 35 years
  • - Large bulla on CT scan were bullectomy is contraindicated or is actively avoided
  • - Hyperinflation --> TLC * 100%predcited and RV * 150% predicted
  • - Exertional breathlessness (mMRC >0)
  • - Optimum COPD treatment for at least 6 weeks
  • - No COPD exacerbation for at least 6 weeks
  • - Fewer than 3 admissions for infective exacerbations in the preceding 12 months
  • - Written informed consent
  • - Patients has stopped smoking for a minimum of 6 months prior to entering the study

排除标准

  • - Inability to obtain informed consent
  • - Co-morbidities that would render bronchoscopy or sedation unsafe
  • - Anaemia or other reasons precluding venesection
  • - Clinically significant bronchiectasis
  • - Arrhythmia or cardiovascular disease that poses a risk during procedure
  • - Lung nodule requiring further investigation or treatment
  • - Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

研究者

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