Bronchoscopic microwave ablation for small lung tumours in surgical candidates

Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

This will try a bronchoscope-delivered microwave device to heat and destroy small lung tumours in adults who are already scheduled for surgical removal.

Quick facts

• Study type: Observational
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Creo Medical Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Milan and 1 other locations)
• Trial ID: NCT06869122 on ClinicalTrials.gov

What this trial studies

This single-arm observational study will use the Creo Medical MicroBlate Flex device to perform bronchoscopic microwave ablation in up to 18 adults with histologically confirmed small lung tumours who are due to have surgical resection. Each participant will undergo bronchoscopic ablation as an additional procedure 7–21 days before their planned surgery, with clinical follow-up at 7 days and again just prior to the operation; surgical pathology will then evaluate the treated tissue. The primary focus is on device safety and performance, including technical success and local tissue effects, rather than long-term outcomes. The study is funded by Creo Medical and will be conducted at specialist centres in the UK and Italy.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed lung cancer who are MDT-listed surgical candidates with a single soft-tissue lung lesion ≤20 mm, at least 10 mm from the pleura or fissure, and fit for general anaesthesia (ASA ≤3).

Not a fit: Patients with centrally located tumours, lesions larger than 20 mm or too close to critical structures or the pleura, those unfit for general anaesthesia, or patients not scheduled for surgical resection are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow some patients with small lung tumours to avoid major surgery, shorten recovery time, and reduce complication rates.

How similar studies have performed: Percutaneous microwave and radiofrequency ablation have shown success for small peripheral lung tumours, but bronchoscopic microwave ablation is a newer, less-tested approach with only limited early feasibility data.

Eligibility criteria

Inclusion Criteria:

Patients who:

1. Have signed informed consent.
2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
3. Are ≥ 18 years old.
4. Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
5. Have soft tissue lung lesion(s):

   * ≤ 20 mm in the largest dimension of the pulmonary window
6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
7. \> 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
8. Subject is willing and able to comply with the study protocol requirements.
9. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion Criteria:

Patients who:

1. Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves).
2. Are pregnant or breast feeding, as determined by standard site practices.
3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
5. Have an expected survival less than 12 months.
6. Have an implantable device, including pacemakers or other electronic implants.
7. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).
8. Subject had a prior pneumonectomy.
9. Diagnosis of Small Cell Lung Cancer.
10. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
11. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Where this trial is running

Milan and 1 other locations

• Istituto Europeo di Oncologia (IEO), Via Ripamonti 435 — Milan, Italy (Not_yet_recruiting)
• Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street — London, UK, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Charlie Campion

Conditions Lung Cancer; Bronchoscopy; Ablation; Microwave; Lung cancer