RecruitingNot ApplicableNCT07291973

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.


Sponsor

Endowave Ltd.

Enrollment

43 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a lung ablation device — a minimally invasive procedure that destroys small tumors in the lung using heat or other energy without surgery — to assess how well it works and how safe it is for small lung tumors. **You may be eligible if...** - You are 18 or older - You have a confirmed malignant (cancerous) nodule in the lung, either a primary lung cancer or a metastasis from another cancer - Your target tumor is 20mm or smaller - There is at least 5mm of healthy lung tissue between the tumor and the lung edge or fissure - You are considered a candidate for lung ablation by your medical team, and surgery is not suitable or you prefer not to have surgery **You may NOT be eligible if...** - Your tumor is touching major airways, large blood vessels, the heart, esophagus, or windpipe - Other health conditions make the ablation procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMicrowave Ablation

FlexAblate Microwave Transbronchial Ablation System


Locations(3)

CMC Ambroise Paré - Hartmann

Paris, France

St. Bartholomew's Hospital

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

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NCT07291973


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