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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRE Cohort | Patients who received SOC and received IRE |
| |
| SOC Cohort | Patients who received SOC and did not receive IRE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOC | Drug | Standard of Care treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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) | Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores Cancer Center, UC San Diego Health | La Jolla | California | 92093 | United States | ||
| University of Florida Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34233640 | Derived | 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. |
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| NanoKnife System |
| Device |
Irreversible Electroporation |
|
| Gainesville |
| Florida |
| 32608 |
| United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Wellstar Medical Group | Marietta | Georgia | 30060 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| University of Iowa Healthcare | Iowa City | Iowa | 52242 | United States |
| Norton Healthcare | Louisville | Kentucky | 40202 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| NYU Langone | New York | New York | 10016 | United States |
| Presbyterian Hospital, Columbia | New York | New York | 10032 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| St. Luke's University Health Network | Easton | Pennsylvania | 18045 | United States |
| University of Texas-Southwestern | Dallas | Texas | 75231 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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