Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2017-12-20
2024-12-31
Brief Summary
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Secondary Objective(s) To collect data on adverse events and complications related to IRE treatment. The AHPBA (Americas Hepato-Pancreato-Biliary Association) will be responsible for data collection and will periodically audit the data for quality assurance purposes. The AHPBA will review outcomes reported by each participating Research Institution and if outcomes are in the lower percentile, the investigators will be offered support to analyze the reasons for the suboptimal outcomes and may seek support to improve outcomes. The participating Research Institutions will receive a certificate annually that acknowledges their participation in the Research Project.
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Detailed Description
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Participants will be followed for 4 years following the NanoKnife procedure. While in the hospital, they will be evaluated within 24-48 hours after the NanoKnife procedure. Additional assessments will be performed prior to being discharged from the hospital. Participants will be asked to return every 3 month follow up to 2 years and then every 6 months after 2 years from IRE. Each visit will last approximately two (2) to three (3) hours at the study doctor's clinic. During these visits, participants will also be asked to report any change in their medications. Except for the study visits, they will not need to visit the study doctor more often than their usual treatment unless they have other medical needs. However, if participants experience any significant change in their medical condition they may be asked to have additional tests such as CT scan, blood tests, etc. Participants will not receive any financial or other compensation for taking part in this study.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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NanoKnife procedure
clinical data regarding use of the NanoKnife system intraoperatively (via laparotomy) to ablate the pancreatic tumors per the treating physicians discretion will be collected.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with pancreatic cancer and has consented to undergo the NanoKnife procedure per the treating physician
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and sign the Informed Consent Form in English or Spanish
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Alejandro Mejia, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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036.HPB.2017.D
Identifier Type: -
Identifier Source: org_study_id
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