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

June 12, 2025 updated by: Englewood Hospital and Medical Center

Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The NanoKnife, System has been commercially available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has received FDA clearance for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

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.

Primary Objective:

• Safety and tolerability of the procedure by monitoring the number of participants with Adverse Events at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure.

Secondary Objective:

• Pain and Quality of Life outcomes of the patient using Pain Scores on the Visual Analogue Score (VAS) and Quality of Life Scores on the EORTC QLQ-PAN26 and EORTC QLQ-C30 at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have unresectable pancreatic cancer following standard chemotherapy with or without radiotherapy will be approached for participation in this study.

Description

Inclusion Criteria:

  • > = 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
  • Are able to comprehend and willing to sign an informed consent form

Exclusion Criteria:

  • 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
  • Known history of contrast allergy that cannot be medically managed
  • Known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
  • Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.)
  • Women who are pregnant or currently breast feeding
  • Women of childbearing potential who are not utilizing an acceptable method of contraception
  • Have taken an investigational agent within 30 days of visit 1
  • Have implanted cardiac pacemakers or defibrillators
  • Have implanted electronic devices or implants with metal parts in the vicinity of a lesion
  • Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
  • Have a recent history of myocardial infarction (within the past 2 months)
  • Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses
  • Evidence of distant metastases of stage IV
  • Have taken any chemotherapeutic agent within 5 weeks of treatment with the NanoKnife Irreversible Electroporation (IRE) System
  • Received non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 Gray (Gy) delivered conventionally

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Pain
Time Frame: 2 years

Safety and tolerability of the procedure by monitoring the number of participants with Adverse Events at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure. The primary endpoint will be the number of Participants with an adverse event related to the IRE treatment and serious or non-serious, at least grade 3, at least possibly related to treatment

This will be measured by a series of questionnaires on pain scores via Quality of Life scores via the EORTC QLQ-PAN26 and EORTC QLQ-C30. Pain will be measured on a scale from 0-10, with 0 being no pain and 10 being worst pain.
2 years
Safety and Pain
Time Frame: 2 years

Safety and tolerability of the procedure by monitoring the number of participants with Adverse Events at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure. The primary endpoint will be the number of Participants with an adverse event related to the IRE treatment and serious or non-serious, at least grade 3, at least possibly related to treatment

This will be measured by a series of questionnaires on pain scores via Visual Analogue Score (VAS).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Englewood Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Estimated)

May 31, 2035

Study Completion (Estimated)

May 31, 2035

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-24-987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe