跳至主要内容
临床试验/NL-OMON56672
NL-OMON56672招募中不适用

Safety and efficacy of a flexible endobronchial sampling instrument that obtains a CORe sample from KeY suspected areas of pulmonary and mediastinal lesions. - COReKeY

Radboud Universitair Medisch Centrum0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30

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

  • All patients with an indication for cone-beam CT guided navigation bronchoscopy
  • for the diagnosis of a peripheral pulmonary nodule are eligible for study
  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • - ASA physical status 1-3
  • - Age above 18 years
  • - A single pulmonary nodule with an indication for diagnostic evaluation
  • following current clinical guidelines
  • - Subject is willing and able to give written informed consent for clinical
  • investigation participation prior to the procedure

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • - Contra-indication for navigation bronchoscopy
  • - Not fit to undergo navigation bronchoscopy
  • - Patient is pregnant
  • - Inability to consent
  • - Less than 18 years old
  • - Contra-indication for temporary interruption of the use of anticoagulant
  • therapy (acenocoumarin, warfarin, therapeutic dose of low molecular weight
  • heparins, clopidogrel or analogs, NOAC*s)
  • - Uncontrolled pulmonary hypertension
  • - Recent and/or uncontrolled cardiac disease
  • - Compromised upper airway (e.g., central airway stenosis for any reason such
  • that endobronchial access is considered unsafe)
  • - Patient is involved in another pulmonary intervention study
  • - Indication for minimal invasive biopsy of multiple nodules in one procedure
  • - Endobronchial visible tumor

研究者

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