Actively Recruiting
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-
Led by Englewood Hospital and Medical Center · Updated on 2025-06-17
25
Participants Needed
1
Research Sites
524 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.
CONDITIONS
Official Title
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with locally advanced unresectable pancreatic cancer after standard chemotherapy and/or radiotherapy
- No chemotherapy or radiotherapy within 5 weeks before NanoKnife treatment
- INR (blood clotting test) less than 1.5
- Willing and able to follow study requirements
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Creatinine level greater than 2.0 mg/dL
- Any severe lab abnormalities graded 3 or 4 by CTCAE Version 5.0
- Unable to stop antiplatelet or coumadin therapy 7 days before and after treatment
- Tumor size not measurable
- Known allergy to contrast dye not manageable
- Known allergy to electrode metal (stainless steel 304L) not manageable
- Cannot receive muscle blockade agents
- Pregnant or breastfeeding women
- Women of childbearing potential not using acceptable contraception
- Taken investigational drugs within 30 days before visit 1
- Have implanted cardiac pacemakers or defibrillators
- Have implanted electronic devices or metal implants near the lesion
- History of epilepsy or cardiac arrhythmia
- Recent heart attack within past 2 months
- Q-T interval greater than 550 ms unless controlled by an approved synchronization system
- Evidence of stage IV distant metastases
- Chemotherapy within 5 weeks before NanoKnife treatment
- Received non-standard radiation schedules or doses higher than 54 Gray
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Englewood Hospital
Englewood, New Jersey, United States, 07631
Actively Recruiting
Research Team
C
Cherif Boutros
CONTACT
J
Jamie Ketas
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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