NCT06937996Recruiting
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 11 Apr 2025
- Start date
- 13 May 2025
- Primary completion date
- 31 May 2035
- Lead sponsor
- Englewood Hospital and Medical Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT06937996
What you commit to
- Study type: Observational
- Planned participants: 25
- From 13 May 2025 to the primary completion date, 31 May 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
- Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.)
- Have taken an investigational agent within 30 days of visit 1
- Have implanted electronic devices or implants with metal parts in the vicinity of a lesion
- Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses
- 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
Other illness
- 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
- Have implanted cardiac pacemakers or defibrillators
- Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
- Have a recent history of myocardial infarction (within the past 2 months)
Lab values
- Creatinine \> 2.0 mg/dL
- Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0
Other
- Tumor size not measurable
- Women who are pregnant or currently breast feeding
- Women of childbearing potential who are not utilizing an acceptable method of contraception
- Evidence of distant metastases of stage IV
Who the study is looking for
- \> = 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Englewood Hospital Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.