FlexAblate microwave treatment for small lung cancer nodules

A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.

This will test whether the FlexAblate microwave ablation system can safely destroy small lung cancer nodules in adults who are not having or are not eligible for surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Endowave Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Paris and 2 other locations)
• Trial ID: NCT07291973 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, non-randomised investigation of the Endowave FlexAblate microwave ablation system in patients undergoing lung ablation. Up to 43 adults with pathologically confirmed primary or metastatic lung nodules ≤20 mm and suitable for percutaneous ablation will be enrolled at up to five sites. Participants will receive a planned microwave ablation procedure and undergo follow-up visits with CT scans at 1 week and 1, 3, 6 and 12 months to monitor safety and local control. The trial will collect device performance and adverse event data to characterize how well the system treats these nodules.

Who should consider this trial

Good fit: Adults (≥18 years) with a pathologically confirmed lung cancer nodule ≤20 mm, at least 5 mm from pleura or fissure, judged suitable for elective microwave ablation and who are not having or decline surgery are ideal candidates.

Not a fit: Patients whose nodules abut major bronchi, large pulmonary vessels, heart, oesophagus or trachea, those who are severely breathless or on home oxygen, or those with uncorrectable bleeding problems are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the device could provide a minimally invasive option to destroy small lung tumors for patients who cannot or do not want surgery.

How similar studies have performed: Prior reports of thermal ablation, including microwave ablation, have shown promising local control for small lung tumors, although randomized comparative evidence versus surgery is limited.

Eligibility 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 this trial is running

Paris and 2 other locations

• 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)

Study contacts

• Study coordinator: Annette Kent, PhD

Conditions Lung Cancer; Microwave Ablation