Actively Recruiting
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
Led by Creo Medical Limited · Updated on 2025-06-26
30
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent is provided.
- Willing and able to follow all study treatment and evaluation requirements.
- Age 18 years or older.
- Lung lesion(s) or nodule(s) confirmed as cancer by pathology.
- Lung lesion size 2 30 mm for Stage A or 2 20 mm for Stage B in the pulmonary window.
- Candidate for surgical resection as determined by a multidisciplinary team or tumor board.
- At least 10 mm of healthy lung tissue between tumor and pleura or fissure.
- Assigned an ASA (American Society of Anaesthesiologists) score of 3 or less, or deemed fit for general anesthesia.
You will not qualify if you...
- Target nodule(s) located in the central zone near critical structures (bronchial tree, major vessels, heart, esophagus, spinal cord, phrenic and laryngeal nerves).
- Pregnant or breastfeeding.
- Participation in another investigational drug or device study within 30 days before enrollment.
- Physical or psychological conditions impairing study participation or safety.
- Expected survival less than 12 months.
- Bleeding disorders or platelet count less than or equal to 100 x 10^9/L.
- Presence of implantable electronic devices like pacemakers.
- Known pulmonary hypertension with systolic pressure over 50 mmHg.
- Use of anticoagulants or platelet inhibitors that cannot be stopped temporarily.
- History of pneumonectomy.
- Diagnosis of Small Cell Lung Cancer.
- Significant interstitial lung disease in the planned ablation area.
- Prior therapeutic intervention (e.g., SBRT) in the same lung lobe.
- Chemotherapy, systemic immunosuppressive therapy, or radiotherapy within 3 months before the study procedure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
Amsterdam, The Netherlands, Netherlands, 1105 AZ
Actively Recruiting
Research Team
C
Charlie Campion
CONTACT
A
Annie Goulding
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here