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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 : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

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].

Condition or disease Intervention/treatment
Stage III Pancreatic Cancer Drug: SOC Device: NanoKnife System

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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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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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
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Alicia Conway 5086587990 ext 7939 aconway@angiodynamics.com

Sponsors and Collaborators
Angiodynamics, Inc.

Additional Information:

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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT03899649     History of Changes
Other Study ID Numbers: 2019-ONC-02
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases