Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue (AB1MALT)
- Conditions
- lung cancerlung carcinoma100729901002910710038737
- Registration Number
- NL-OMON56949
- 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. Are >= 18 years old.
3. Have lung lesion(s)/nodule(s) which are histopathologically confirmed or are
highly suspicious for cancer and is a candidate for bronchoscopic microwave
ablation (as determined by a multi-disciplinary team (MDT) or tumour board).
4. Have medically inoperable soft tissue lung lesion(s) <= 20 mm (suspected or
confirmed malignancy), or a 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.
Patients who: 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 bleeding diathesis, uncorrectable
coagulopathy or platelet count <= 100 x 10* /L. 9. Have an implantable device,
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 can*t 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method