CRONOS-1: Transbronchial Cryo-Assisted Hybrid RadioFrequency Ablation of Malignant Pulmonary Nodules: An immediate Treat-and- resect Study

Macquarie University0 个研究点目标入组 5 人开始时间: 2026年8月24日最近更新: 2026年8月3日

适应症

试验速览

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•Age equal to or greater than 18-years-old
•Ability to read, understand, and sign the participant’s Informed Consent Form (ICF)
•Histologically confirmed malignant pulmonary nodule of less than or equal to 25mm in maximum diameter in size and planned for surgical resection as per MDT consensus
•MDT consensus recommendation for surgical resection of the target nodule
•Suitable candidate for surgical resection of the target nodule
•More than 20 mm between the calculated intended ablation zone and any critical structures (pleura, large vessels and main bronchi).

•Pregnant or nursing (breastfeeding)
•Central tumours abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea)
•Clinical management relying on further post-surgical histopathological information e.g for molecular or PDL-1 studies.
•Thoracic electronic implants (e.g., pacemakers, ICDs)
•Uncorrectable coagulopathy or platelet count less than or equal to 50,000/mm3
•Severe, uncontrolled comorbidities
•Active systemic infection
•Prior radiation therapy in the intended ablation zone
•Recent Investigational therapy within the last 30 days
•Tumours associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis
•Investigators determine that study participation poses a safety risk
•Any comorbidities judged by the investigators to be contraindicated for bronchoscopy
•Subject deemed unsuitable for study participation by the Investigator for any reason

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