NCT07291973Recruiting
Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.
A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 24 Oct 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Endowave Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07291973
What you commit to
- Study type: Interventional
- Planned participants: 43
- From 24 Oct 2025 to the primary completion date, 31 Dec 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are extremely breathless or on home oxygen therapy.
- Subjects with prior pneumonectomy.
- Subjects who have had any radiation (i.e., SBRT or EBRT) to the intended ablation zone or lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation).
- Subjects who have implantable electronic devices, including pacemakers or other electronic implants.
- Participation in an investigational drug or device clinical investigation within 30 days of enrolment that would interfere with this clinical investigation.
Other illness
- Target nodule is abutting main or lobar stem bronchus, main pulmonary vasculature (vessel 5mm), heart, oesophagus and/or trachea.
- Known pulmonary hypertension (Pulmonary artery systolic pressure, PASP \>50mmHg).
- Active active pulmonary infection at time of screening or the procedure.
Lab values
- Subjects medically unable to stop anticoagulant or anti-platelet therapy for relevant time period prior to and following the ablation procedure.
Other
- Female subjects who are pregnant or nursing.
- Subjects with uncorrectable coagulopathy or thrombocytopenia at time of screening.
- The investigator determines that participation in this clinical investigation may jeopardise the safety or welfare of the subject.
Who the study is looking for
- Adult ≥ 18 years of age who has provided signed informed consent.
- 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 metastatic disease.
- Target nodule is ≤ 20mm in maximum diameter.
- There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure.
- Subject is a candidate for an elective lung ablation procedure as determined by institutional multi-disciplinary board or equivalent.
- Subject or the lesion is not suitable for surgery or patient refuses surgery.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMC Ambroise Paré - Hartmann Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.