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A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Study acronym: DIRECT
StatusActive, Not Recruiting
PhaseNot specified
Started
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.

Record History

  1. Primary and study completion dates: Dec 2024 to Apr 2025v12
  2. Primary and study completion dates: Dec 2023 to Dec 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 14
    v11
  3. Site details revised at 7 of 15 sitesv10
  4. Study sites: 19 to 15v9
  5. Study sites: 20 to 19v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 18 to 20v7
  2. Study sites: 7 to 18v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 3 to 7v4
  5. Study sites: 2 to 3v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2019 to May 8, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 \[SOC cohort\].
Trial Details
NCT Number NCT03899649
Lead Sponsor Angiodynamics, Inc.
Conditions
(from sponsor)		 Stage III Pancreatic Cancer
Related terms Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms
Enrollment 532 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov