Fact CheckerSign in

NCT03899649Active, not recruiting

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

Source: ClinicalTrials.gov · Last updated 12 Feb 2025

Brief summary (registry, in English)

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 \[SOC cohort\].

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
532 (estimated)
First submitted
29 Mar 2019
Start date
8 May 2019
Primary completion date
Apr 2025
Lead sponsor
Angiodynamics, Inc.
NCT number
NCT03899649

What you commit to

  • Study type: Observational
  • Planned participants: 532
  • From 8 May 2019 to the primary completion date, Apr 2025
  • 14 sites 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

  • Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy

Other illness

  • Participation in an interventional trial for pancreatic cancer during the study data collection period
  • Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE

Other

  • Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade

Who the study is looking for

  • Provisions of signed and dated informed consent form
  • Patient is 18 years of age and older
  • Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
  • Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
  • Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
  • Patient has received 3 months of SOC per each participating institution's guidelines
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
  • Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
  • Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Northwest Community Hospital
Coordinator of this site? Confirm its status
Arlington HeightsUnited StatesUnknown status
Atrium Health
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
University of Texas, Southwestern
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
St. Luke's University Health Network
Coordinator of this site? Confirm its status
EastonUnited StatesUnknown status
University of Florida Health
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
University of Iowa Healthcare
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
Moores Cancer Center UC San Diego Health
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Norton Healthcare
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Wellstar Medical Group
Coordinator of this site? Confirm its status
MariettaUnited StatesUnknown status
Miami Cancer Institute
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
NYU Langone
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Presbyterian Hospital, Columbia
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mayo Clinic - Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Barnes-Jewish Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.