Comparing outcomes of Bronchoscopic Robot (ION) with Endobronchial Ultrasound (EBUS) Guide sheath sampling of lung nodules- diagnostic yield and resource utilisation.

Royal Brisbane and Womens Hospital0 个研究点目标入组 70 人开始时间: 2023年8月15日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•Patient is suitable for elective nodule biopsy via bronchoscopy under general anaesthesia per Investigator’s discretion.
•Patient has solid or semi-solid pulmonary nodule(s) of 8 mm to 30 mm in largest dimension (based on pre-procedure CT scan)
•Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 airway generations out (trachea is generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan
•Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease.
•Patient is willing and able to give written informed consent for Clinical Investigation participation.
•Patient is not legally incapacitated or in a legal/court ordered institution.

•Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure.
•Presence of suspicious mediastinal nodal disease on pre-procedure CT or PET-CT scan.
•Requirement for any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule or suspected disease state.
•Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
•Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
•Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
•Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation.
•Patient is not willing to comply with post study procedure participation requirements.

发起方

Royal Brisbane and Womens Hospital