CClinicalTrials.gg
Sign In
RecruitingNCT06937996Updated Jun 17, 2025

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

An observational study in Pancreatic Cancer Non-resectable, sponsored by Englewood Hospital and Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Englewood Hospital and Medical Center · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Pancreatic Cancer Non-resectable
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 25 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Englewood Hospital and Medical Center is the lead sponsor of 24 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • DeviceNanoKnife

    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.

06

What researchers measure

Primary outcomes

  1. Safety and Pain

    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.

    Time frame: 2 years

  2. Safety and Pain

    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).

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Englewood Hospital
    Englewood, New Jersey 07631, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06937996
Lead sponsor
Englewood Hospital and Medical Center
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
May 13, 2025
Primary completion
May 31, 2035 (estimated)
Completion
May 31, 2035 (estimated)
Last update
Jun 17, 2025

Study contacts

Cherif Boutros
Contact
Cherif.Boutros@EHMCHealth.org
(201) 608-2266
Jamie Ketas
Contact
jamie.ketas@ehmchealth.org
201-894-3418

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pancreatic Neoplasms→

Other studies from this sponsor

Englewood Hospital and Medical Center

Start the discussion