NCT03899649Active, not recruiting
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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 \[SOC cohort\].
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 532 (estimated)
- First submitted
- 29 Mar 2019
- Start date
- 8 May 2019
- Primary completion date
- Apr 2025
- Lead sponsor
- Angiodynamics, Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT03899649
What you commit to
- Study type: Observational
- Planned participants: 532
- From 8 May 2019 to the primary completion date, Apr 2025
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participation in an interventional trial for pancreatic cancer during the study data collection period
- 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
Other
- Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwest Community Hospital Coordinator of this site? Confirm its status | Arlington Heights | United States | Unknown status |
| Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| St. Luke's University Health Network Coordinator of this site? Confirm its status | Easton | United States | Unknown status |
| University of Florida Health Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| University of Iowa Healthcare Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Moores Cancer Center UC San Diego Health Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Norton Healthcare Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Wellstar Medical Group Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| NYU Langone Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Presbyterian Hospital, Columbia Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.