NCT03899649

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 532 (estimated)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	SOC	Standard of Care treatment
DEVICE	NanoKnife System	Irreversible Electroporation

Timeline

• Start date: 2019-05-08
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2019-04-02
• Last updated: 2025-02-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study