Bronchoscopic Microwave Ablation of Lung Tissue

Korábbi kezelés

• Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
• Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
• Have an implantable devices, including pacemakers or other electronic implants.
• 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.
• Subject had a prior pneumonectomy.

Más betegség

• a. Target nodule(s) are within 10mm of the trachea, right and left main bronchus, aorta, central pulmonary arteries, heart, oesophagus, spinal cord, phrenic \& laryngeal nerves.
  • Note: Exclusion Criteria 1a is UK-specific.
  • For patients undergoing procedures without the use of robotic-assisted bronchoscopy (manual procedures):
• b. 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 and laryngeal nerves), or are <10 mm from the pleura.
• Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
• Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg).
• Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
  • Note: Exclusion Criteria 12 is NL-specific.

Laborértékek

• Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.
• Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which cannot be stopped or temporarily withheld.

Egyéb

• The participant may not be enrolled in the study if ANY of the following apply:
• For patients undergoing procedures employing robotic-assisted bronchoscopy:
• Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
• Are pregnant or breast feeding, as determined by standard site practices.
• Have an expected survival less than 6 months.

• The participant may enter the study if ALL of the following apply:
• The patient:
• Has signed the informed consent form
• Are ≥ 18 years old
• 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).
• 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.
• Patient is a candidate for bronchoscopy under general anaesthesia.
• Subject is willing and able to comply with the study protocol requirements.
• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.