AHPBA Pancreatic Irreversible Electroporation (IRE) Registry

AHPBA Pancreatic Irreversible Electroporation (IRE) Registry for Pancreatic Cancer

  • Clinical Trial Information

    Trial Contact: De Leon, Ma Theresa; Marchese, Sean N

    Trial Phone: 321.841.8284 ; 321.841.4348

  • IRB No: 17.027.03

    Protocol Abbrev: AHPBA Registry

    Principal Investigator: Debashish Bose, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: AHPBA Registry_NanoKnife

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT02674100

  • Objective

    The primary objective of this study is to observe progression-free survival. Secondary objectives are to gather data on overall survival, procedure outcomes in subpopulations, treatment protocols, adverse events and complications related to NanoKnife IRE treatment.

  • Key Eligibility

    Ages Eligible for Study: 18 Years and older (Adult, Senior)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No
    Sampling Method: Non-Probability Sample
    Inclusion Criteria
    Patients must meet all of the following criteria to be included in the study:
    1. Diagnosed with pancreatic cancer
    2. Able to comprehend and have signed the Informed Consent Form
    Exclusion Criteria
    Patients who meet any of the following criteria will be excluded from the study:
    1. Have a cardiac pacemaker or ICD implanted
    2. Have non-removable implants with metal parts ≤1 cm of target lesion that would impact IRE delivery
    3. Had a myocardial infarction within 3 months prior to enrollment