A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
tumor ablation system in IRE method
Meir Medical Center
Kfar Saba, Israel
RECRUITINGUniversity Hospital Complex of Salamanca
Salamanca, Spain
RECRUITINGRoyal Brompton Hospital
London, United Kingdom
RECRUITINGSafety of the EAS1 System in Lung Tumor Ablation During Procedure
Accumulative rate of device related Serious Adverse Events (SAEs) during the ablation and up to 48 hours post ablation
Time frame: 48 hours post procedure
Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up
Rate of device related SAEs during the follow up period
Time frame: 30 days
Investigator's Ability to Approach and Ablate the Tumor (Technical Success)
\- Technical success, defined as the investigator's ability to access the target tumor and successfully perform the irreversible electroporation, as confirmed by histology analysis
Time frame: 30 days
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