Actively Recruiting
The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Led by HistoSonics, Inc. · Updated on 2026-01-15
50
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
CONDITIONS
Official Title
The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older.
- Subject has signed the Ethics Committee approved Informed Consent Form and agrees to follow trial procedures and follow-up.
- Subject has unresectable pancreatic adenocarcinoma (Stage 3 or Stage 4) confirmed by CT or MR imaging within 14 days before treatment.
- For Stage 4, there must be 5 or fewer metastatic tumors only in the liver and/or lung, and these tumors must be stable.
- Subject is not a surgical candidate and has had chemotherapy for at least 8 weeks.
- Subject can tolerate general anesthesia.
- Subject has an ECOG Performance Status grade 0 or 1 at baseline.
- Subject meets specific laboratory criteria within 14 days before treatment, including hemoglobin ≥ 9 g/dL, neutrophil count > 1.0 x 10^9/L, platelet count > 50 x 10^9/L, total bilirubin ≤ 2.5 times institutional upper limit, AST and ALT ≤ 2.5 times institutional upper limit, INR < 1.5, and serum creatinine < 2.0 mg/dL or eGFR ≥ 45 mL/min.
- The targeted pancreatic tumor is at least 2 cm in longest diameter.
- The planned treatment area is at least 1.0 cm away from portions of the duodenum, small intestine, stomach, or colon as seen on imaging.
- Subject has an adequate acoustic window to visualize the tumor using the device.
- Subject will have histotripsy treatment of only one tumor during the procedure.
You will not qualify if you...
- Subject is pregnant, planning to become pregnant, or nursing during the trial.
- Subject has had previous pancreatic, bilioenteric, or gastric surgery.
- Subject is currently in another drug or device trial that could interfere with this study’s results.
- Subject has an uncorrectable bleeding disorder.
- Subject has a life expectancy less than six months.
- Subject has a biliary or pancreatic stent or percutaneous biliary tube covering the treatment area.
- Subject has metastases to organs other than liver or lungs (such as bone, brain, or peritoneum).
- Subject is allergic to contrast media and cannot be pre-medicated.
- Subject has an active duodenal or gastric ulcer needing medical treatment.
- Subject has received chemotherapy within 7 days before treatment.
- Subject has received immunotherapy or targeted therapies within 30 days before treatment.
- Subject’s tumor has had prior local treatments like ablation, embolization, or radiation.
- Subject has planned cancer treatments other than chemotherapy within 30 days after treatment.
- Subject has planned chemotherapy within 14 days after the procedure.
- Subject has not recovered from chemotherapy or immunotherapy side effects except for hair loss, neuropathy, or exocrine insufficiency.
- Investigator believes histotripsy is not suitable for the subject.
- Subject has conditions that could risk safety or affect study compliance.
- Subject’s tumor is not treatable within the device’s operating range.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
Research Team
Z
Zoe Secord
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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