Lung Cancer
Conditions
Keywords
Bronchoscopy, Ablation, Microwave, Lung cancer
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAblation
Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.
Sponsors
Creo Medical Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who: 1. Have signed informed consent. 2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. 3. Are ≥ 18 years old. 4. Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer. 5. Have soft tissue lung lesion(s): * ≤ 20 mm in the largest dimension of the pulmonary window 6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board. 7. \> 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure. 8. Subject is willing and able to comply with the study protocol requirements. 9. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.
Exclusion criteria
Patients who: 1. Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves). 2. Are pregnant or breast feeding, as determined by standard site practices. 3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study. 4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject. 5. Have an expected survival less than 12 months. 6. Have an implantable device, including pacemakers or other electronic implants. 7. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg). 8. Subject had a prior pneumonectomy. 9. Diagnosis of Small Cell Lung Cancer. 10. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion. 11. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the MicroBlate Flex AB1 system in lung tumour ablation | Up to 21 days after the ablation procedure | 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) |
| Technical Success and Performance of the AB1 instrument | Up to 28 days post ablation procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion | Up to 1 week post surgical resection procedure | 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 |
| Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT | Up to 1 week post ablation procedure | Dimensions of the ablated tissue as evidenced on the post-ablation CT |
| Procedural Time | Up to 1 week post ablation procedure | Procedural time to be captured in the electronic case report form |
| Assessment of ease of system use (Clinician Questionnaires) | Up to 1 week post ablation procedure | 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" |
Countries
Italy, United Kingdom
Contacts
CONTACTCharlie Campion
CONTACTAnnie Goulding
Outcome results
None listed