Bronchoscopic Microwave Ablation of Lung Tissue

Trial Title: Bronchoscopic Microwave Ablation of Lung Tissue

NCT ID: NCT05786625

Condition: Lung Cancer

Conditions: Keywords:
Neoplasms
Bronchoscopy
Ablation
Microwave

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Ablation
Description: Bronchoscopy and microwave ablation of lung nodule
Arm group label: Microwave ablation

Summary: The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules.

Detailed description: This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 32 subjects in total (plus replacements) at up to 6 clinical investigation sites in Europe and potentially 1 site in the US. Prospective patients must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry. Patients who meet the eligibility requirements will undergo a pre-procedural assessment, a bronchoscopy procedure that includes ablation treatment with MicroBlate™ Flex AB1, a post-procedural assessment and 6 follow-up visits at, 7 days (by phone call or in person), 31-45 days, 3 months, 6 months, 9 months and 12 months.

Criteria for eligibility:

Study pop:
Subjects enrolled in the proposed study must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. Patients without a histologically confirmed diagnosis of cancer may be enrolled if a multi-disciplinary board deems that it is highly likely that their lung lesion is a malignancy.

Sampling method: Non-Probability Sample
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 & 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] - amp;gt;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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Royal Brompton and Harefield NHS Foundation Trust

Address:
City: London
Zip: SW3 6NP
Country: United Kingdom

Status: Recruiting

Start date: May 4, 2023

Completion date: March 2026

Lead sponsor:
Agency: Creo Medical Limited
Agency class: Industry

Source: Creo Medical Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05786625