Registry to Evaluate Effectiveness and Safety of the Nanoknife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

About this Study

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].

Sponsor Protocol ID:2019-ONC-02
IRB Number:2020-0169
Actively Enrolling
Observational
Observational/Not Applicable
July 17, 2020
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
A potential patient will be included in the study if he/she
meets all the following 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


Exclusion Criteria
A potential patient will be excluded from the study if he/she
meets any of the following 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

Categories Click category to view its trials.
Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Sandra Powe
Phone Number: 601-815-5288
Email: spowe@umc.edu
Principal Investigator:Earl, Truman M, M.D.
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