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Purpose

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].

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provisions of signed and dated informed consent form 2. Patient is 18 years of age and older 3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria 4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery 5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC 6. Patient has received 3 months of SOC per each participating institution's guidelines 7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2. 9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System 10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Exclusion Criteria

  1. Participation in an interventional trial for pancreatic cancer during the study data collection period 2. Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy 3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade 4. Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
IRE Cohort Patients who received SOC and received IRE
  • Drug: SOC
    Standard of Care treatment
  • Device: NanoKnife System
    Irreversible Electroporation
SOC Cohort Patients who received SOC and did not receive IRE
  • Drug: SOC
    Standard of Care treatment

More Details

Status
Active, not recruiting
Sponsor
Angiodynamics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.