A Registry Study Of NanoKnife IRE For Stage 3 Pancreatic Cancer

Study Overview

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) [IRE cohort], and patients who were treated with SOC and did not receive IRE [SOC cohort].

N/A

Stage III Pancreatic Cancer

DRUG: SOC
DEVICE: NanoKnife System

2019-ONC-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-03-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-11
First Submitted that Met QC Criteria 2019-04-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-12
First Posted (ACTUAL) 2019-04-02	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: IRE Cohort Patients who received SOC and received IRE	DRUG: SOC Standard of Care treatment DEVICE: NanoKnife System Irreversible Electroporation
: SOC Cohort Patients who received SOC and did not receive IRE	DRUG: SOC Standard of Care treatment

Participant Group/Arm

Intervention/Treatment

: IRE Cohort

Patients who received SOC and received IRE

DRUG: SOC

Standard of Care treatment

DEVICE: NanoKnife System

Irreversible Electroporation

: SOC Cohort

Patients who received SOC and did not receive IRE

DRUG: SOC

Standard of Care treatment

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)	Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record