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Irreversible Electroporation

IRE Cohort for Pancreatic Cancer (DIRECT Trial)

N/A
Waitlist Available
Research Sponsored by Angiodynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
Awards & highlights

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 \[SOC cohort\].

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: SOC CohortExperimental Treatment1 Intervention
Patients who received SOC and did not receive IRE
Group II: IRE CohortExperimental Treatment2 Interventions
Patients who received SOC and received IRE
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SOC
2022
Completed Phase 3
~4430
NanoKnife System
2017
N/A
~20

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Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
23 Previous Clinical Trials
1,815 Total Patients Enrolled
~16 spots leftby Dec 2024
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