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

NCT02041936 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-02-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the short and intermediate term outcomes of the NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating symptoms of unresectable pancreatic cancer. 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.

Irreversible electroporation (IRE) has the potential to dramatically widen the treatment options for patients with pancreatic cancer. It provides a minimally invasive procedure that could potentially avoid radical surgery for smaller lesions, and it could potentially offer palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with locally advanced unresectable disease.

Conditions

  • Unresectable Pancreatic Cancer

Interventions

DEVICE

NanoKnife IRE System

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Cherif Boutros, MD · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041936 on ClinicalTrials.gov