An observational study in Stage III Pancreatic Cancer, sponsored by Angiodynamics, Inc.. Active, not recruiting at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Angiodynamics, Inc. · Observational
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].
3,311 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 532 is above the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with cytologically or pathologically confirmed Stage 3 PC who are treated, in real-world treatment settings and as part of routine clinical practice, with the NanoKnife System (at least 266 patients) for the ablation of their tumor in addition to SOC (IRE cohort), or with SOC only (at least 266 patients) (SOC cohort). Patients will be enrolled after completing the initial 3-month treatment per SOC for Stage 3 PC.
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Exclusion Criteria:
Patients who received SOC and received IRE
Drug: SOC · Device: NanoKnife System
Patients who received SOC and did not receive IRE
Drug: SOC
Standard of Care treatment
Irreversible Electroporation
Overall Survival
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)
Time frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
Started May 2019 (actual). Primary completion is estimated for Apr 2025, 71 months after the start.
Of 305 observational studies under Pancreatic Neoplasms, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 206. This study's planned 71 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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