Clinical Trial

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Study acronym: DIRECT
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 12, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.
Summary
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 \[SOC cohort\].
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2019-04-01; most recent amendment 2025-02-11.
Status change: Recruiting → Active, Not Recruiting 2024-01-30
Status change: Not Yet Recruiting → Recruiting 2019-07-02
Trial Details
NCT Number NCT03899649
Lead Sponsor Angiodynamics, Inc.
Conditions Stage III Pancreatic Cancer
Enrollment 532 participants
Start Date 2019-05-08
Primary Completion 2025-04 (estimated)
Study Completion 2025-04 (estimated)
Updated on ClinicalTrials.gov 2025-02-12