At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Microwave Ablation (device)
- How long the study runs
- Study runs about 26 months (dates as stated)
- About the drug or intervention
- Microwave Ablation — device: FlexAblate Microwave Transbronchial Ablation System
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a device called the Endowave FlexAblate Microwave Ablation System, which uses heat to destroy small cancer spots in the lung. The study will check how well the device works, how safe it is, and what benefits it may bring to patients having lung ablation. It is for people with confirmed lung cancer who cannot have, or do not want, surgery.
Who can take part
- Adults aged 18 or over who agree in writing to take part
- Able and willing to attend the planned study follow-up appointments
- Have a confirmed cancerous nodule (lump) in the lung, either a primary cancer or one that has spread from elsewhere
- The target nodule is 20mm or smaller across at its widest point
- There is at least 5mm of healthy lung between the nodule and the lung's outer lining (pleura) or a fissure
- A hospital team has decided the person is suitable for a planned lung ablation procedure
- The person or the nodule is not suitable for surgery, or the person chooses not to have surgery
Who may not be able to
- The nodule touches a main airway (bronchus), a large blood vessel (5mm or bigger), the heart, the gullet (oesophagus) or the windpipe (trachea)
- People who are extremely breathless or use oxygen at home
- People who are pregnant or breastfeeding
- Blood clotting problems that cannot be corrected at the time of screening
- People who have previously had a whole lung removed (pneumonectomy)
- Certain treatments to the same area in the last 30 days (such as lung ablation, surgery, or radiotherapy including SBRT or EBRT), or planned treatment on the same lung before the 30-day check
- People with implanted electronic devices, such as pacemakers
- Known high pressure in the lung arteries (pulmonary artery systolic pressure over 50mmHg)
- An active chest or lung infection at screening or at the time of the procedure
- People who cannot safely stop blood-thinning or anti-platelet medicines around the time of the procedure
- Taking part in another study drug or device trial within 30 days of joining this study, if it would interfere with this study
- The investigator believes taking part could put the person's safety or welfare at risk
What taking part involves
- • A lung ablation procedure using the Endowave FlexAblate Microwave Ablation System, which uses microwave energy (heat) to destroy the target nodule
- • Not stated — ask the trial team about other tests, scans or follow-up details
Time commitment: Not stated — ask the trial team about visits and duration; the data mentions a follow-up schedule and a check 30 days after the ablation.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 43
- Started
- 2025-10-24
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for lung cancer
- • NA - 43 participants
- • The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with lung cancer
Where?
- • London - St. Bartholomew's Hospital
- • London - University College London Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system. Participants in this clinical trial will be patients aged over 18 years who have been previously diagnosed with cancer in the lung (primary or secondary malignant tumours) and deemed unsuitable for surgery or are declining surgery or, patients suitable for microwave ablation procedure based on clinical assessment. Those who meet all of the eligibility criteria at a screening assessment (a review of eligibility to participate in the study includes review of information on the cancerous nodule, recording your medical history, current medications, a blood test, and quality of life assessments) will undergo the ablation treatment with FlexAblate™ Microwave Ablation System. Follow-up assessments will be at week 1 and months 1, 3, 6 and 12 will includes CT Scans (CT or "CAT" scan is a computed tomography scan), blood tests, assessment of overall health and quality of life assessments.
More detail
This is a prospective, single-arm, non-randomised clinical investigation. Up to 43 subjects will be enrolled from up to 5 sites. The clinical investigation is designed to evaluate the performance and safety of the Endowave FlexAblate™ Microwave Ablation System device in subjects undergoing lung ablation procedures. Microwave Ablation System device in subjects undergoing lung ablation procedures.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Adult ≥ 18 years of age who has provided signed agreement to take part.
- ✓Subject is able and willing to comply with the planned clinical investigation follow-up schedule
- ✓Pathological confirmed malignant nodule in the lung either primary or that has spread disease.
- ✓Target nodule is ≤ 20mm in maximum diameter.
- ✓There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure.
Who cannot take part
- ✗Target nodule is abutting main or lobar stem bronchus, main lung vasculature (vessel 5mm), heart, oesophagus...
- ✗Subjects who are extremely breathless or on home oxygen therapy.
- ✗Female subjects who are pregnant or nursing.
- ✗Subjects with uncorrectable coagulopathy or thrombocytopenia at time of screening.
- ✗Subjects with prior pneumonectomy.
See the full criteria
Where Is This Study? (2 UK sites)
St. Bartholomew's Hospital
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
How to Get in Touch
Annette Kent, PhD
Sponsor contactCONTACT
