A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer (DIRECT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03899649 |
Recruitment Status :
Recruiting
First Posted : April 2, 2019
Last Update Posted : December 20, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Stage III Pancreatic Cancer | Drug: SOC Device: NanoKnife System |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 532 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 24 Months |
Official Title: | Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma |
Actual Study Start Date : | May 8, 2019 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2023 |

Group/Cohort | Intervention/treatment |
---|---|
IRE Cohort
Patients who received SOC and received IRE
|
Drug: SOC
Standard of Care treatment Device: NanoKnife System Irreversible Electroporation |
SOC Cohort
Patients who received SOC and did not receive IRE
|
Drug: SOC
Standard of Care treatment |
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Provisions of signed and dated informed consent form
- Patient is 18 years of age and older
- Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
- Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
- Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
- Patient has received 3 months of SOC per each participating institution's guidelines
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
- Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
- Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC
Exclusion Criteria:
- Participation in an interventional trial for pancreatic cancer during the study data collection period
- 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
- Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899649
Contact: Elizabeth Manning | (339) 237-2765 | liz.manning@angiodynamics.com |
United States, California | |
Moores Cancer Center, UC San Diego Health | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Shakeela Dad | |
Principal Investigator: Rebekah White, MD | |
University of California, Irvine | Recruiting |
Orange, California, United States, 92868 | |
Contact: Rebecca Freeman freemar1@hs.uci.edu | |
Principal Investigator: Nadine Abi-Jaoudeh, MD | |
United States, Florida | |
University of Florida Health | Active, not recruiting |
Gainesville, Florida, United States, 32608 | |
Miami Cancer Institute | Recruiting |
Miami, Florida, United States, 33176 | |
Contact: Ernesto Cue Barroso | |
Principal Investigator: Govindarajan Narayanan, MD | |
United States, Georgia | |
Wellstar Medical Group | Active, not recruiting |
Marietta, Georgia, United States, 30060 | |
United States, Illinois | |
Northwest Community Hospital | Recruiting |
Arlington Heights, Illinois, United States, 60005 | |
Contact: Karen Zwicky | |
Principal Investigator: Malcolm M Bilimoria, MD | |
United States, Iowa | |
University of Iowa Healthcare | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Laura Jacobus | |
Principal Investigator: Carlos Chan, MD | |
United States, Kentucky | |
Norton Healthcare | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Mary Healey | |
Principal Investigator: Robert Martin, MD, PhD, FACS | |
United States, Minnesota | |
Mayo Clinic, Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Danielle Patnode | |
Principal Investigator: Sean Cleary, MD | |
United States, Missouri | |
Barnes-Jewish Hospital | Active, not recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
NYU Langone | Recruiting |
New York, New York, United States, 10016 | |
Contact: Xiaohong Jing | |
Principal Investigator: Theodore Welling, MD | |
Presbyterian Hospital, Columbia | Recruiting |
New York, New York, United States, 10032 | |
Contact: Susie Flores | |
Principal Investigator: Michael Kluger, MD | |
United States, North Carolina | |
Atrium Health | Active, not recruiting |
Charlotte, North Carolina, United States, 28204 | |
United States, Pennsylvania | |
St. Luke's University Health Network | Active, not recruiting |
Easton, Pennsylvania, United States, 18045 | |
United States, Texas | |
University of Texas-Southwestern | Active, not recruiting |
Dallas, Texas, United States, 75231 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Angiodynamics, Inc. |
ClinicalTrials.gov Identifier: | NCT03899649 |
Other Study ID Numbers: |
2019-ONC-02 |
First Posted: | April 2, 2019 Key Record Dates |
Last Update Posted: | December 20, 2022 |
Last Verified: | December 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Pancreas Cancer Pancreatic Adenocarcinoma Pancreatic Ductal Adenocarcinoma Advanced Pancreatic Cancer Carcinoma, Pancreatic Ductal Locally Advanced Pancreatic Cancer |
Cancer of Pancreas Pancreatic Tumor Pancreatic Carcinoma Unresectable Pancreatic Cancer LAPC |
Pancreatic Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |