Spots Global Cancer Trial Database for The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
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Trial Identification
Brief Title: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Official Title: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Study ID: NCT06282809
Study Description
Brief Summary: The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
Detailed Description: This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinoma tumors in patients who are diagnosed with unresectable locally advanced (Stage 3) or oligometastatic disease (Stage 4). The type of design is exploratory and is considered interventional. Following histotripsy, subjects will undergo imaging ≤36-hours post-index procedure. Additionally, subjects will be followed at 7-day, 14-day, 30-day, 60-day, 120-day, and 180-day timepoints.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Contact Details
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