A prospective, single-arm, non-randomized, single-center, open-label, treat and resect study following patients through surgical resection. The study is designed to evaluate the safety and feasibility of the Aliya EX System for the ablation of pulmonary lesions using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed pulmonary malignant lesion(s) ≥1.5 cm to ≤4 cm whom are surgical candidates and have not received treatment for the index tumor in the last two years.
This study is to evaluate the safety and technical success of delivering Aliya® pulsed electric fields (Aliya PEF) for ablation of pulmonary lesions in patients with suspected or confirmed malignancy, prior to planned surgical resection. Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations: Bronchoscopic approach: Aliya® EX Generator, the INUMI Flex Needle and the Aliya® Electrode. Percutaneous approach: Aliya® EX Generator, the Aliya® Needle and the Aliya® Electrode. The study will enroll and treat up to 25 adult patients with suspected or confirmed pulmonary malignant lesion(s) in patients whom are surgical candidates at 1 clinical site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Pulsed electric field treatment using the Aliya EX System
Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGDevice and Procedure related serious adverse event rate
Rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Time frame: From the PEF procedure through surgical resection (approximately 30 days later)
Technical success
The frequency with which the clinician can access the target lesion and deliver PEF energy
Time frame: Intra-procedural
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