Microwave ablation for lung cancer treatment

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

This study is testing a new microwave treatment for lung cancer to see if it's safe and works well for people with lung nodules.

Quick facts

• Study type: Observational
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Creo Medical Limited (Industry-sponsored)
• Locations: 2 sites (Amsterdam and 1 other locations)
• Trial ID: NCT05786625 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument for bronchoscopic microwave ablation of peripheral lung nodules in patients with lung cancer. It will enroll up to 32 subjects across multiple clinical sites in Europe and potentially one in the US. Participants will undergo a screening visit, followed by a bronchoscopy procedure that includes the ablation treatment, and will be monitored through several follow-up visits over the course of a year.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed or highly suspicious lung nodules that are medically inoperable and suitable for bronchoscopic microwave ablation.

Not a fit: Patients with operable lung lesions or those whose nodules are not suitable for the procedure will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a minimally invasive treatment option for patients with inoperable lung cancer.

How similar studies have performed: Other studies have shown promise with similar microwave ablation techniques, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

The participant may enter the study if ALL of the following apply:

The patient:

1. Has signed the informed consent form
2. Are ≥ 18 years old
3. Has lung lesion(s)/nodule(s) which are histologically confirmed or highly suspicious for cancer and is a candidate for bronchoscopic microwave ablation (as determined by a multi-disciplinary team (MDT) or tumour board).
4. Has a medically inoperable soft tissue lung lesion(s) ≤ 20 mm (suspected or confirmed malignancy), or patient has elected not to have surgery / alternative therapy.
5. Patient is a candidate for bronchoscopy under general anaesthesia.
6. Subject is willing and able to comply with the study protocol requirements.
7. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion Criteria:

The participant may not be enrolled in the study if ANY of the following apply:

1. Target nodule(s) are within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord and phrenic and laryngeal nerves), or are \<10 mm from the pleura.
2. Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
3. Are pregnant or breast feeding, as determined by standard site practices.
4. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
5. Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
6. Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
7. Have an expected survival less than 6 months.
8. Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.
9. Have an implantable devices, including pacemakers or other electronic implants.
10. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg).
11. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which cannot be stopped or temporarily withheld.
12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
13. Patient has nodal disease confirmed through invasive or image-based staging. Note: if nodal disease is suspected or detected during the staging procedure conducted prior to use of the investigational device during the study procedure, the subject will be excluded.
14. Subject had a prior pneumonectomy.

Where this trial is running

Amsterdam and 1 other locations

• Amsterdam University Medical Centres, Location AMC, Meibergdreef 9 — Amsterdam, Netherlands (Recruiting)
• Royal Brompton and Harefield NHS Foundation Trust — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Pallav L Shah, MD — Royal Brompton and Harefield NHS Foundation Trust
• Study coordinator: Charlie Campion

Conditions Lung Cancer; Neoplasms; Bronchoscopy; Ablation; Microwave