Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06689488
• Lead Sponsor: Creo Medical Limited

Brief Summary

The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.

Detailed Description

This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out).

Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. 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.

The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer.

Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Study Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-14
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	Day 7-21, post ablation procedure up to initiation of surgical resection procedure.	Stage B - Ablate (Day 0) \& Resect (Resection Day 7-21) Identification of serious device-related adverse events related to the use of the AB1 system from day 0 up to initiation of surgical resection procedure (number and nature of serious adverse events, both device and procedure related, will be identified).
Primary Performance (Efficacy) Endpoint	Up to 1 week post ablation procedure.	Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion.

Secondary Outcome Measures

Name	Time	Method
Secondary Performance (Efficacy) Endpoints - Procedural Time	Up to 1 week post ablation procedure.	Procedural time to be captured in the electronic case report form (eCRF).
Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion	Up to 1 week post ablation procedure.	Dimensions of the ablated tissue to confirm, correct or add to the IFU-reported relationship between AB1 ablation time and dimensions and volume of the ablated tissue, per pre-specified target.
Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT	Up to 1 week post ablation procedure.	Dimensions of the ablated tissue as evidenced on the post ablation CT.
Secondary Performance (Efficacy) Endpoints - Assessment of ease of system use (clinician questionnaires)	Up to 1 week post ablation procedure.	Questionnaires to be completed by clinicians, rating their responses on a Likert scale of 1 to 7, with 1 being "extremely clear/easy" and 7 being "extremely difficult".

Trial Locations

Locations (1)

Amsterdam University Medical Centres, Location AMC, Meibergdreef 9; 🇳🇱 Amsterdam, The Netherlands, Netherlands