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OpenTrials
Active, Not Recruiting

NCT Number: NCT03899649

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].

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moores Cancer Center, UC San Diego Health, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Participation in an interventional trial for pancreatic cancer during the study data collection period
  • 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
  • Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
  • 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

Treatment and study plan

SoC

Drug

Standard of Care treatment

NanoKnife System

Device

Irreversible Electroporation

Primary outcomes

  1. Overall Survival

    Time frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.

    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)

Sponsors and collaborators

Lead sponsor

Angiodynamics, Inc.

Industry

Registry information

Official study title

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

Acronym: DIRECT

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2019
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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