NL-OMON53517招募中不适用
AirWaze - easy and advanced tools for CBCT guided lung interventions - AirWaze
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Philips
- 入组人数
- 37
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 18 years or older at the time of informed consent.
- •ASA physical status between 1 and 3.
- •Subject is willing and able to give written informed consent for clinical
- •investigation participation prior to the procedure.
- •Subject has a pulmonary lesion with an indication for diagnostic evaluation
- •following current clinical guidelines and/or as decided by multi-disciplinary
- •team consultation.
- •Suitable for CBCT-guided endobronchial nodule biopsy under general
- •anaesthesia.
- •Pre-procedural (PET-)CT scan is available prior to the CBCT-NB intervention.
排除标准
- •Aged 17 or younger at the time of informed consent.
- •ASA physical status is equal to and greater than 4.
- •Not willing or not able to give informed consent.
- •Does not indicate diagnostic evaluation with navigation bronchoscopy.
- •Not suitable for CBCT-guided endobronchial nodule biopsy via navigation
- •bronchoscopy under general anaesthesia.
- •There is no recent pre-procedural (PET-)CT scan available.
- •Known bleeding disorders.
- •Contra-indication for temporary interruption of the use of anticoagulant
- •therapy, such as acenocoumarol, warfarin, therapeutic dose of low molecular
- •weight heparins, clopidogrel, or analogues, NOACs).
- •Known allergy for lidocaine or other allergies interfering with the procedure.
- •Uncontrolled pulmonary hypertension.
- •Recent and/or uncontrolled cardiac disease.
- •Compromised upper airway (e.g. concomitant head and neck cancer or central
- •airway stenosis for any reason such that endobronchial access is considered
- •Potentially confounding drug or device trial during the course of the
- •clinical study. Co-enrollment in concurrent trials may be allowed provided
- •pre-approval is obtained from the Philips Clinical Study Manager.
- •All vulnerable subjects, such as immune-compromised subjects, subjects
- •lacking the capacity to provide consent, patients in emergencies, pregnant or
- •breastfeeding women, or any other subject who meets exclusion criteria,
- •according to applicable national laws, if any.
- •Woman of childbearing potential who is known to be pregnant on admission.
- •Any condition that in the judgment of the investigator could impose hazards
- •to the patient if study therapy is initiated or affect the participation of the
- •subject in the study.
- •Subject is Philips employee or their family members residing with this
- •Philips employee.
研究者
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