Netherlands, United Kingdom35 participantsStarted 2023-05-04
Plain-language summary
The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlateā¢ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Has signed the informed consent form
ā. Are ā„ 18 years old
ā. 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).
ā. Has a medically inoperable soft tissue lung lesion(s) ā¤ 20 mm (suspected or confirmed malignancy), or patient has elected not to have surgery / alternative therapy.
ā. Patient is a candidate for bronchoscopy under general anaesthesia.
ā. Subject is willing and able to comply with the study protocol requirements.
ā. Are assigned an ASA (American Society of Anaesthesiologists) score of ā¤ 3 or the patient is deemed fit for general anaesthesia.
Exclusion criteria
ā. 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.
ā. Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
ā. Are pregnant or breast feeding, as determined by standard site practices.
ā. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
What they're measuring
1
Primary Performance (Efficacy) Endpoint
Timeframe: Up to day 30 patient visit.
2
Primary Safety Endpoint
Timeframe: Up to 30 days after the ablation procedure.
ā. Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
ā. Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
ā. Have an expected survival less than 6 months.
ā. Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ā¤ 100 x 10ā¹ /L.