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Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.

Sponsor: Endowave Ltd.

NCT ID: NCT07291973

View on ClinicalTrials.gov ↗

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.

Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

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
Inclusion Criteria: * 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. Exclusion Criteria: * Target nodule is abutting main or lobar stem bronchus, main pulmonary vasculature (vessel 5mm), heart, oesophagus and/or trachea. * 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. * 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. * Known pulmonary hypertension (Pulmonary artery systolic pressure, PASP \>50mmHg). * Active active pulmonary infection at time of screening or the procedure. * Subjects medically unable to stop anticoagulant or anti-platelet therapy for relevant time period prior to and following the ablation procedure. * Participation in an investigational drug or device clinical investigation within 30 days of enrolment that would interfere with this clinical investigation. * The investigator determines that participation in this clinical investigation may jeopardise the safety or welfare of the subject.

Where Is This Study? (2 UK sites)

St. Bartholomew's Hospital

London, United Kingdom

Recruiting

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Annette Kent, PhD

Sponsor contact

CONTACT

+353868584016 clinical@endowave.ie
Data sourced from ClinicalTrials.gov · Last verified: 2026-04