Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK (NCT06869122) | Clinical Trial Compass
RecruitingNot Applicable
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
Italy, United Kingdom18 participantsStarted 2025-07-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the MicroBlate Flex AB1 system in lung tumour ablation
Timeframe: Up to 21 days after the ablation procedure
2
Technical Success and Performance of the AB1 instrument
. Subject is willing and able to comply with the study protocol requirements.
Exclusion criteria
. 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).
. Are pregnant or breast feeding, as determined by standard site practices.
. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
. Have an expected survival less than 12 months.
. Have an implantable device, including pacemakers or other electronic implants.
. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).