CT-controlled advanced navigation techniques for transbronchial pulmonary lesion access; evaluation of electromagnetic navigation based diagnostic yield. - CONTROL-E

Radboud Universitair Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•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 18 years or older.
•* A pulmonary lesion (i.e. a focal, rounded opacity mostly surrounded by aerated lung or a ground glass opacity or part- or sub-solid lesion) with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•* Bleeding disorders.
•* Less than 18 years old.
•* Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines, clopidrogel or analogs, NOAC*s).
•* Known allergy for lidocaine.
•* 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 unsafe).
•* ASA classification greater than or equal to 4 (unfit for performing non-surgical biopsy).
•* Pregnancy.
•* Inability to consent.

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