跳至主要内容
临床试验/NCT04214587
NCT04214587招募中不适用

Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months

研究概览

简要总结

Rationale:

COPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone/nitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.

Objective:

The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Elidgible for EBV treatment

排除标准

  • Anticoagulation which cannot be stopped prior to the procedure

结局指标

主要结局

the % of the 150 patients that will develop a need for rebronchoscopy after 18 months

时间窗: 18 months

frequency

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dirk-Jan Slebos

Prof. dr. D.J. Slebos MD, PhD, Principle Investigator

University Medical Center Groningen

研究点 (1)

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