Ablation: Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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
Trial sites (2)
Facility
City
Region
Status
Istituto Europeo di Oncologia (IEO), Via Ripamonti 435
Milan
Italy
Not Yet Recruiting
Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.