Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEnglewood Hospital and Medical Center

About this trial

The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.

Eligibility criteria

Qualifiers

> = 18 years of age

Must be found to have locally advanced unresectable disease following standard chemotherapy ± radiotherapy as demonstrated with either CT/MRI imaging and surgical evaluation, and not have taken any chemotherapy/radiotherapy within 5 weeks of treatment with the NanoKnife IRE System

Must have an INR < 1.5

Are willing and able to comply with the protocol requirements

Disqualifiers

Creatinine > 2.0 mg/dL

Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0

Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System

Tumor size not measurable

Trial design

Treatments tested in this trial

  • NanoKnife

Treatment groups

No treatment groups listed