First Human Use of a New Robotic ElectrOmagnetic Navigation Bronchoscopy with Integrated Tool-In-Lesion-Tomosynthesis (TiLT) TEchnology (Galaxy SystemTM) for Small PeRipheral Pulmonary Nodules

oah Medical Inc0 个研究点目标入组 18 人开始时间: 2022年11月10日最近更新: 2024年2月12日

适应症

试验速览

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•Age greater than or equal to 18 years of age
•Patients with a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information, determined by the Interventional Pulmonary Nodule MDT based on the site’s standard of care
•Solid peripheral pulmonary nodules (PPNs) sized 1 to 3 cm measured as the largest dimension
•Pre-procedural CT is conducted within 30 days of the bronchoscopy procedure
•Peripheral Pulmonary Nodules that are accessible bronchoscopically on planning CT reconstruction based on MDT discussion
•Informed consent properly obtained per local regulations

•Known pregnancy or breastfeeding
•Patients with a subsolid nodule (pure or partly solid ground-glass nodules) on pre-procedural chest CT
•Uncontrolled coagulopathy or bleeding disorders
•Ongoing systemic infection
•Past history of lobectomy
•Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
•Moderate-to-severe hypoxia, hypoxemia, or hypercarbia
•Patients with implanted pacemakers or defibrillators
•Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
•Patients who are unable to provide written informed consent to participate in the study

发起方

oah Medical Inc