The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.
This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out). Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry. The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer. Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study). Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).
Study Type
OBSERVATIONAL
Enrollment
30
Bronchoscopy and microwave ablation prior to surgical resection.
Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
Amsterdam, The Netherlands, Netherlands
RECRUITINGPrimary Safety Endpoint
Stage A - Ablate (Day 0) \& Resect (Day 0) Identification of serious device-related intra-procedural adverse events related to the use of the AB1 system on Day 0 prior to surgical resection defined by the initial skin incision (number and nature of serious adverse events, both device and procedure related, will be identified).
Time frame: Day 0, day of ablation procedure up to initiation of surgical resection procedure.
Primary Safety Endpoint
Stage B - Ablate (Day 0) \& Resect (Resection Day 7-21) Identification of serious device-related adverse events related to the use of the AB1 system from day 0 up to initiation of surgical resection procedure (number and nature of serious adverse events, both device and procedure related, will be identified).
Time frame: Day 7-21, post ablation procedure up to initiation of surgical resection procedure.
Primary Performance (Efficacy) Endpoint
Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of 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 1 week post ablation procedure.
Secondary Performance (Efficacy) Endpoints - 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 ablation procedure.
Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dimensions of the ablated tissue as evidenced on the post ablation CT.
Time frame: Up to 1 week post ablation procedure.
Secondary Performance (Efficacy) Endpoints - Procedural Time
Procedural time to be captured in the electronic case report form (eCRF).
Time frame: Up to 1 week post ablation procedure.
Secondary Performance (Efficacy) Endpoints - Assessment of ease of system use (clinician questionnaires)
Questionnaires to be completed by clinicians, 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.