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
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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