Microwave ablation of lung tissue in patients eligible for surgery

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

This study is testing a new tool to see if it can safely treat lung cancer in patients who are also planning to have surgery.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Creo Medical Limited (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Amsterdam, The Netherlands)
• Trial ID: NCT06689488 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and effectiveness of the Creo Medical MicroBlate™ Flex AB1 instrument for patients with confirmed lung cancer who are candidates for surgical resection. It involves two stages: Stage A, where ablation and surgery occur simultaneously, and Stage B, where they are performed separately. The study will enroll up to 30 participants and will follow local guidelines for lung cancer treatment, with evaluations conducted post-ablation and prior to surgery for Stage B patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed lung cancer lesions eligible for surgical resection.

Not a fit: Patients with target nodules that do not meet the size or location criteria for ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and reduce complications for lung cancer patients.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the use of ablation techniques for lung cancer treatment.

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):

   * ≤ 30 mm in the largest dimension of the pulmonary window for Stage A.
   * ≤ 20 mm in the largest dimension of the pulmonary window for Stage B.
6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
7. Greater than 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 bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10\^9/L.
7. Have an implantable device, including pacemakers or other electronic implants.
8. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).
9. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
10. Subject had a prior pneumonectomy.
11. Diagnosis of Small Cell Lung Cancer.
12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
13. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
14. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Where this trial is running

Amsterdam, The Netherlands

• Amsterdam University Medical Centres, Location AMC, Meibergdreef 9 — Amsterdam, The Netherlands, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Jouke T Annema, MD — Amsterdam University Medical Centres
• Study coordinator: Charlie Campion

Conditions: Lung Cancer, Bronchoscopy, Ablation, Microwave, Lung cancer