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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, the investigators 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 sites in the UK and Italy, 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:
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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 of the lung tumour prior to surgical resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety 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) | 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 | Up to 28 days post ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 surgical resection procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of immunological response following microwave ablation procedure | Immunological response, as determined by change from baseline to pre-surgical resection in immunological and inflammatory blood markers | Up to 28 days post ablation procedure |
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.
> 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 site.
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Europeo di Oncologia (IEO), Via Ripamonti 435 | Not yet recruiting | Milan | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637 | ||
| Background | SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019. | ||
| 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. | |
| 18242243 |
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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.
| 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 |
| Procedural Time | Procedural time to be captured in the electronic case report form | 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" | Up to 1 week post ablation procedure |
| Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street | Recruiting | London | UK | SW3 6NP | United Kingdom |
|
| 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. |
| 16631680 | Background | 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. |
| 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |