The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHistoSonics, Inc.
About this trial
The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is ≥18 years of age.
Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
Subject is diagnosed with unresectable pancreatic adenocarcinoma (locally advanced [Stage 3] or oligometastatic disease [Stage 4]) confirmed via CT or MR imaging ≤14 days prior to the planned index procedure.
Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.
Disqualifiers
Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
Subject has had prior pancreatic, bilioenteric, or gastric surgery.
Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.
Subject has an uncorrectable coagulopathy.
Trial design
Design model
Single group
Treatments tested in this trial
HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
DeviceHistotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: HistoSonics SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy
Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). \[Clinical Events Committee Adjudicated\]
Time frame
30 days post histotripsy procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov