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A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer (DIRECT)

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ClinicalTrials.gov Identifier: NCT03899649
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : December 20, 2022
Information provided by (Responsible Party):
Angiodynamics, Inc.

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 2, 2019
Last Update Posted Date December 20, 2022
Actual Study Start Date May 8, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2019)
Overall Survival [ Time Frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months. ]
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
Official Title Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
Brief 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].
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Stage III Pancreatic Cancer
  • Drug: SOC
    Standard of Care treatment
  • Device: NanoKnife System
    Irreversible Electroporation
Study Groups/Cohorts
  • IRE Cohort
    Patients who received SOC and received IRE
    • Drug: SOC
    • Device: NanoKnife System
  • SOC Cohort
    Patients who received SOC and did not receive IRE
    Intervention: Drug: SOC
Publications * Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 1, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Provisions of signed and dated informed consent form
  2. Patient is 18 years of age and older
  3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
  4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
  5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
  6. Patient has received 3 months of SOC per each participating institution's guidelines
  7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
  9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
  10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Exclusion Criteria:

  1. Participation in an interventional trial for pancreatic cancer during the study data collection period
  2. Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
  3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
  4. Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Elizabeth Manning (339) 237-2765 liz.manning@angiodynamics.com
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03899649
Other Study ID Numbers 2019-ONC-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Current Responsible Party Angiodynamics, Inc.
Original Responsible Party Same as current
Current Study Sponsor Angiodynamics, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Angiodynamics, Inc.
Verification Date December 2022