Lung CancerAURORANCT07291973
Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.
A study testing Microwave Ablation in people with Lung Cancer, run by Endowave Ltd. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Microwave Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
St. Bartholomew's Hospital
London
Kelvin Lau, +442074804794, bartshealth.thoracicsecretaries@nhs.et
- Recruiting
University College London Hospitals NHS Foundation Trust
London
Ricky Thakrar, ricky.thakrar@ucl.ac.uk
France1 site, 1 recruiting
- Recruiting
CMC Ambroise Paré - Hartmann
Paris
Agathe Seguin, +33 1 46 41 31 53, agathe.seguin@clinique-a-pare.fr
About this study
Official title: A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- Microwave Ablation
- Keywords
- Lung Cancer, Microwave Ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave AblationDevice
FlexAblate Microwave Transbronchial Ablation System
| Study group | Role | What they receive |
|---|---|---|
| Transbronchoscopic Microwave Ablation | Experimental | The FlexAblate™ Microwave Ablation System is deployed and used to conduct bronchoscopic ablations in the lung. Receives: Device: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Efficacy
Technical Efficacy defined as ablation of the target tumour with the ablation zone completely overlapping or encompassing the entire target tumour assessed using conventional CT imaging.
Measured: 1 month
Secondary outcomes (7)
Procedure Technical Success
Procedure technical success defined by the investigator as successful deployment, activation and removal of the ablation catheter according to the investigation plan.
Measured: Day of procedure
Ablation Technical Success
Ablation technical success defined as the nodule treated according to the investigation plan and covered completely by the ablation zone with an adequate margin assessed using CT imaging.
Measured: At Discharge - Day 1
Safety Assessment - number of device or procedure related Serious Adverse Events
Number of Serious Adverse events (SAE) related to the device or procedure associated with the use of the FlexAblate System.
Measured: Through to 1 month follow-up
Safety Assessment - number of device or procedure related Adverse Events (AE)
Number of Adverse Events (AE) related to the device or procedure.
Measured: Through to 3 months
Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30)
Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much").
Measured: 12 months
Quality of Life Assessment - EQ-5D-5L health-related quality of life questionnaire
Patients complete the 5 level descriptive system relating to 5 dimensions of health and the EQ visual analogue scale from 0 to 100 (where 0 means the worst health you can imagine and 100 means the best health you can imagine).
Measured: 12 months
Quality of Life Assessment - Bronchoscopic Ablation Patient Pain and Satisfaction Survey
Survey completed by the patient to assess their pain and satisfaction with the ablation procedure.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start24 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, non-randomised clinical investigation.
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endowave Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291973
- Sponsor's protocol ID
- EDW-CID-001
- Acronym
- AURORA
- Status last verified
- Apr 2026
- First submitted
- 25 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.
- ClinicalTrials.gov ID
- NCT07291973
- Acronym / sponsor ID
- AURORA / EDW-CID-001
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Microwave Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Endowave Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, non-randomised clinical investigation.
| Arm | Type | Receives |
|---|---|---|
| Transbronchoscopic Microwave Ablation | Experimental | Device: Microwave AblationThe FlexAblate™ Microwave Ablation System is deployed and used to conduct bronchoscopic ablations in the lung. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave AblationFlexAblate Microwave Transbronchial Ablation System | Device | Transbronchoscopic Microwave Ablation |
Primary outcome
Technical Efficacy
Time frame: 1 month
Technical Efficacy defined as ablation of the target tumour with the ablation zone completely overlapping or encompassing the entire target tumour assessed using conventional CT imaging.
7 secondary outcomes
Procedure Technical Success
Time frame: Day of procedure
Ablation Technical Success
Time frame: At Discharge - Day 1
Safety Assessment - number of device or procedure related Serious Adverse Events
Time frame: Through to 1 month follow-up
Safety Assessment - number of device or procedure related Adverse Events (AE)
Time frame: Through to 3 months
Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30)
Time frame: 12 months
Quality of Life Assessment - EQ-5D-5L health-related quality of life questionnaire
Time frame: 12 months
Quality of Life Assessment - Bronchoscopic Ablation Patient Pain and Satisfaction Survey
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Ablation in people with Lung Cancer, run by Endowave Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Kent, PhD (+353868584016, clinical@endowave.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Efficacy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.