This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, we are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours. The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure. The study, funded by Creo Medical, will be conducted at a single site in the UK, and will involve up to 18 participants.
Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation. There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital. Participation in this study has the potential to provide the following benefits for other people who have the same medical condition: * The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure. * Shorter patient recovery times. * Reduced incidence of complications.
Study Type
OBSERVATIONAL
Enrollment
18
Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.
Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street
London, UK, United Kingdom
RECRUITINGSafety of the MicroBlate Flex AB1 system in lung tumour ablation
Identification of serious device-related adverse events associated with the delivery of microwave energy by the AB1 system from ablation (Day 0) up to the first surgical incision for the resection (Day 7-21)
Time frame: Up to 21 days after the ablation procedure
Technical Success and Performance of the AB1 instrument
Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of the scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion
Time frame: Up to 28 days post ablation procedure
Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion
Dimensions of the ablated tissue to confirm, correct or add to the IFU-reported relationship between AB1 ablation time and dimensions and volume of the ablated tissue, per pre-specified target
Time frame: Up to 1 week post surgical resection procedure
Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT
Dimensions of the ablated tissue as evidenced on the post-ablation CT
Time frame: Up to 1 week post ablation procedure
Procedural Time
Procedural time to be captured in the electronic case report form
Time frame: Up to 1 week post ablation procedure
Assessment of ease of system use (Clinician Questionnaires)
Questionnaires to be completed by clinicians following each procedure, rating their responses on a Likert scale of 1 to 7, with 1 being "extremely clear/easy" and 7 being "extremely difficult"
Time frame: Up to 1 week post ablation procedure
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