Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates (AB1MALTISC)
- Conditions
- lung cancerlung carcinoma100386661002910710038737
- Registration Number
- NL-OMON56952
- Lead Sponsor
- Creo Medical Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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 histopathologically
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.
> 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.
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* /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 invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method