Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
This study is a prospective, single-arm, single-center, study to evaluate the safety and technical feasibility of using the phenoWave MW Ablation System to deliver microwave energy for ablation of lesions in the lung.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.
Royal Melbourne Hospital
Melbourne, Victoria, Australia
RECRUITINGSafety - AE occurrence
Incidence of complications and occurrence of Adverse Events (AEs)
Time frame: up to 7 days post ablation
Safety - AE frequency
Frequency of AEs
Time frame: up to 7 days post ablation
Safety - ablated tissue assessment
Percentage of ablated tissue within tumor boundary as assessed on gross and/or histologic evaluation
Time frame: up to 7 days post ablation
Technical Feasibility
Evidence of thermal ablation in portion of the tumor as assessed on histopathology
Time frame: up to 7 days post ablation
Navigational Success
Measured distance of phenoWave device tip relative to the planned position from CT data
Time frame: Immediately after completion of procedure (day 0)
Procedural Measures
Total procedure time and navigation time to position the device
Time frame: Immediately after completion of procedure and navigation to the target (day 0)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.