Initial study to evaluate local control and the preferred method of attachment of the
CivaSheet in the setting of suspected close or positive margins at the time of surgical
tumor removal.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02843945.
This is a Feasibility study to determine the safety and efficacy of a new brachytherapy
device that provides unidirectional radiation which utilizes active components
(Palladium-103) of standard devices in a novel configuration.This pilot study may benefit
pancreatic cancer patients by reducing the radiation dose to adjacent critical
structures, while giving a therapeutic dose to diseased tissue, such as at a surgical
margin. The appropriate dose and local control rate will be recorded the primary endpoint
in order to provide an efficacy assessment.
Lead OrganizationCivaTech Oncology
