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The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlateâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave ablation | Patients with a malignant lung nodule who are candidates for surgical resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Bronchoscopy and microwave ablation prior to surgical resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary 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). | 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). | 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. | Up to 1 week post ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 week post ablation procedure. |
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Inclusion Criteria:
Patients who:
Have signed informed consent.
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
Are ≥ 18 years old.
Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer.
Have soft tissue lung lesion(s):
Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
Subject is willing and able to comply with the study protocol requirements.
Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.
Exclusion Criteria:
Patients who:
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General population going through lung cancer screening at investigative sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlie Campion | Contact | +44 7939 600137 | Charlie.Campion@creomedical.com | |
| Annie Goulding | Contact | +44 1291 606 005 | Annie.Goulding@creomedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Jouke T Annema, MD | Amsterdam University Medical Centres | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Centres, Location AMC, Meibergdreef 9 | Recruiting | Amsterdam | The Netherlands | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15126658 | Background | Covey AM, Gandhi R, Brody LA, Getrajdman G, Thaler HT, Brown KT. Factors associated with pneumothorax and pneumothorax requiring treatment after percutaneous lung biopsy in 443 consecutive patients. J Vasc Interv Radiol. 2004 May;15(5):479-83. doi: 10.1097/01.rvi.0000124951.24134.50. | |
| 16631680 | Background |
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Summary aggregate information will be published in a PRJA at the conclusion of the study.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Resected lung tissue and blood samples.
| Secondary Performance (Efficacy) Endpoints - 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. | 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). | 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". | Up to 1 week post ablation procedure. |
| Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048. |
| 18242243 | Background | Boffa DJ, Allen MS, Grab JD, Gaissert HA, Harpole DH, Wright CD. Data from The Society of Thoracic Surgeons General Thoracic Surgery database: the surgical management of primary lung tumors. J Thorac Cardiovasc Surg. 2008 Feb;135(2):247-54. doi: 10.1016/j.jtcvs.2007.07.060. Epub 2007 Dec 21. |
| 28581404 | Background | Chen H, Senan S, Nossent EJ, Boldt RG, Warner A, Palma DA, Louie AV. Treatment-Related Toxicity in Patients With Early-Stage Non-Small Cell Lung Cancer and Coexisting Interstitial Lung Disease: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):622-631. doi: 10.1016/j.ijrobp.2017.03.010. Epub 2017 Mar 15. |
| Background | SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019 |
| Background | Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |