None listed
Conditions
Brief summary
CRONOS-1 is a prospective, single-arm, single-centre feasibility study evaluating the use of the HybridTherm® cryo-assisted radiofrequency ablation (cryoRFA) system to ablate histologically confirmed malignant pulmonary nodules via a flexible bronchoscopic approach. Five participants with nodules less than or equal to 25 mm, already planned for surgical resection as standard of care, will undergo transbronchial cryoRFA immediately prior to their planned surgery under the same general anaesthetic. The resected specimen is then assessed by histopathology to evaluate ablation effects. The study aims to establish whether the device can be safely and successfully deployed bronchoscopically, and to characterise the immediate histopathological ablation zone in human lung tissue. There are no additional hospital visits; all study activities occur within the index surgical admission. The study is conducted at Macquarie University Hospital, NSW, Australia, and is funded by Erbe Elektromedizin GmbH with Macquarie University as sponsor.
Interventions
Participants with histologically confirmed malignant pulmonary nodules less than or equal to 25mm undergo transbronchial cryo-assisted radiofrequency ablation (cryoRFA) using the HybridTherm® bipolar eTip® probe (OD 1.9 mm, length 1.25 m; Erbe Elektromedizin GmbH) immediately prior to planned standard-of-care surgical resection, under the same general anaesthetic. The interventional Pulmonologist will be completing the intervention.
The procedure is performed via robotic-assisted bronchoscopy
Participants with histologically confirmed malignant pulmonary nodules less than or equal to 25mm undergo transbronchial cryo-assisted radiofrequency ablation (cryoRFA) using the HybridTherm® bipolar eTip® probe (OD 1.9 mm, length 1.25 m; Erbe Elektromedizin GmbH) immediately prior to planned standard-of-care surgical resection, under the same general anaesthetic. The interventional Pulmonologist will be completing the intervention. The procedure is performed via robotic-assisted bronchoscopy (RAB) with Cone-Beam CT (CBCT) or digital tomography (DT) guidance. The HybridTherm® probe is navigated to the target nodule and ablation is performed in cryoRFA mode (CO2-cooled bipolar RF delivery). Ablation duration is individualised based on lesion size and location, ranging from 5 to 15 minutes per session. A tipCUT mode is used for transbronchial access; trackCOAG and softCOAG modes are available for procedural haemostasis. The probe position and estimated ablation zone are confirmed by intra-procedural advanced imaging (CBCT/DT) prior to and at the conclusion of energy delivery. Following ablation, participants proceed immediately to surgical resection of the ablated nodule under the same anaesthetic. There are no additional study visits beyond the Day 1 follow-up. The total participant duration is approximately 4 weeks (from screening to Day 1 follow-up).
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age equal to or greater than 18-years-old 2. Ability to read, understand, and sign the participant’s Informed Consent Form (ICF) 3. 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 4. MDT consensus recommendation for surgical resection of the target nodule 5. Suitable candidate for surgical resection of the target nodule 6. More than 20 mm between the calculated intended ablation zone and any critical structures (pleura, large vessels and main bronchi).
Exclusion criteria
1. Pregnant or nursing (breastfeeding) 2. Central tumours abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea) 3. Clinical management relying on further post-surgical histopathological information e.g for molecular or PDL-1 studies. 4. Thoracic electronic implants (e.g., pacemakers, ICDs) 5. Uncorrectable coagulopathy or platelet count less than or equal to 50,000/mm3 6. Severe, uncontrolled comorbidities 7. Active systemic infection 8. Prior radiation therapy in the intended ablation zone 9. Recent Investigational therapy within the last 30 days 10. Tumours associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis 11. Investigators determine that study participation poses a safety risk 12. Any comorbidities judged by the investigators to be contraindicated for bronchoscopy 13. Subject deemed unsuitable for study participation by the Investigator for any reason
Outcome results
None listed