NCT06937996 · Englewood Hospital and Medical Center
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-
What this study is about
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 effectiveness of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.
View original scientific description
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.
Interventions
DEVICE
NanoKnife
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.
Primary outcome measures
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.
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Englewood, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2025 · Source of record for eligibility and locations