This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) \[IRE cohort\], and patients who were treated with SOC and did not receive IRE \[SOC cohort\].
Study Type
OBSERVATIONAL
Enrollment
532
Standard of Care treatment
Irreversible Electroporation
Moores Cancer Center, UC San Diego Health
La Jolla, California, United States
University of Florida Health
Gainesville, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Wellstar Medical Group
Marietta, Georgia, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
University of Iowa Healthcare
Iowa City, Iowa, United States
Norton Healthcare
Louisville, Kentucky, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
NYU Langone
New York, New York, United States
...and 4 more locations
Overall Survival
To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)
Time frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
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