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

NCT07291973 | Recruiting DMC

• 1 other identifier: EDW-CID-001
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Microwave Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Procedure Technical Success

  Day of procedure

• Ablation Technical Success

  At Discharge - Day 1

• Safety Assessment - number of device or procedure related Serious Adverse Events

  Through to 1 month follow-up

• Safety Assessment - number of device or procedure related Adverse Events (AE)

  Through to 3 months

• Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30)

  12 months

Other Outcomes (5)

• Ablation zone size assessment

  Discharge - Day 1

• Assessment of Local Control

  12 months

• Device user experience

  Day of procedure

Study Arms (1)

Transbronchoscopic Microwave Ablation

EXPERIMENTAL

The FlexAblate™ Microwave Ablation System is deployed and used to conduct bronchoscopic ablations in the lung.

Device: Microwave Ablation

Interventions

Microwave Ablation DEVICE

FlexAblate Microwave Transbronchial Ablation System

Transbronchoscopic Microwave Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endowave Ltd.: lead

Study Sites (3)

CMC Ambroise Paré - Hartmann

Paris, France

RECRUITING

St. Bartholomew's Hospital

London, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Annette Kent, PhD

CONTACT

+353868584016; clinical@endowave.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, non-randomised clinical investigation.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); FR (1)