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临床试验/DRKS00011372
DRKS00011372招募中1 期

Endoscopic thermal vapor ablation in patients with homogenous lung emphysema-a pilot study

Thoraxklinik Universitätsklinikum Heidelberg0 个研究点目标入组 10 人开始时间: 2016年11月23日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
30 Years 至 one(—)
性别
All

入选标准

  • Serious pulmonary emphysema:
  • FEV1 <45%, RV> 150%, TLC> 100%, maximum drug therapy according to GOLD
  • blood gases:
  • PO2> 45 mmHg at room air at rest; PCO2 <55 mmHg with room air at rest
  • -Homogeneity:
  • Homogenous pulmonary emphysema, which was already detected prior to study inclusion by a thoracic HCRT and a perfusion scintigraphy; Confirmation of homogeneity by computer-assisted emphysem quantification (YACTA®)
  • -patient age:> 30 years
  • -Stable COPD:
  • No exacerbation in the last 8 weeks; Cortisone dose <20 mg prednisolone equivalent
  • -Not- or ex-smoker:
  • Nicotine abstinence> 4 months; Current CoHb <2.5%
  • -Patient informed consent:
  • Signed patient information for an endoscopic LVR; Willingness to participate in the control investigations according to the protocol

排除标准

  • -Nutritional status:
  • BMI <18 mg / kg²
  • Significant bronchiectasis:
  • Sputum quantity> 4 tablespoons /day
  • -physical resilience:
  • Walking distance <140 m
  • - Difficult cardiac disease:
  • Z. n. Myocardial infarction in the last 6 weeks; Decompensated heart failure; Cardio-myopathy with medium to highly limited LVF; Long term medication with Clopidogrel
  • -Pre-operations:
  • Z.n. Lung resection (LVRS / lobectomy / pneumonectomy)
  • -Pregnancy:
  • Existing pregnancy; Female subject of childbearing age without adequate contraception

研究者

发起方
Thoraxklinik Universitätsklinikum Heidelberg

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