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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Microwave Ablation

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 Type: Interventional
• Enrollment (Estimated): 43
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annette Kent, PhD; Phone Number: +353868584016; Email: clinical@endowave.ie

Study Locations

• France
  • Paris, France
    • Recruiting
    • CMC Ambroise Paré - Hartmann
    • Contact: Agathe Seguin; Phone Number: +33 1 46 41 31 53; Email: agathe.seguin@clinique-a-pare.fr
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College London Hospitals NHS Foundation Trust
    • Contact: Ricky Thakrar; Email: ricky.thakrar@ucl.ac.uk
  • London, United Kingdom
    • Recruiting
    • St. Bartholomew's Hospital
    • Contact: Kelvin Lau; Phone Number: +442074804794; Email: bartshealth.thoracicsecretaries@nhs.et

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transbronchoscopic Microwave Ablation; The FlexAblate™ Microwave Ablation System is deployed and used to conduct bronchoscopic ablations in the lung.	Device: Microwave Ablation; FlexAblate Microwave Transbronchial Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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").	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).	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.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation zone size assessment	Evaluation of the ablation zone size defined as the radiologic region or zone of induced treatment effect by CT imaging.	Discharge - Day 1
Assessment of Local Control	Assessment of target tumour local control defined as local suspicious growth under CT imaging at the originally ablated target tumour within or abutting the ablation zone.	12 months
Device user experience	Device user experience questionnaire completed at the time of the procedure by the investigator or physician performing the ablation.	Day of procedure
Assessment of pulmonary function	Completion of Pulmonary Function Tests to assess pulmonary function.	12 months
Ablation ablative margin assessment	Evaluation of the size of the ablation margin defined as the ablation beyond the borders of the tumor by CT imaging.	Discharge - Day 1

Collaborators and Investigators

• Sponsor: Endowave Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Microwave Ablation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: EDW-CID-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No