A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
NCT03899649 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 532
Last updated 2025-02-12
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 \[SOC cohort\].
Conditions
- Stage III Pancreatic Cancer
Interventions
- DRUG
-
SOC
Standard of Care treatment
- DEVICE
-
NanoKnife System
Irreversible Electroporation
Sponsors & Collaborators
-
Angiodynamics, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-08
- Primary Completion
- 2025-04-30
- Completion
- 2025-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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