Pancreas CancerGANNONNCT06282809
The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
A study testing HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy in people with Pancreas Cancer and Adenocarcinoma of the Pancreas, run by HistoSonics, Inc. at 1 site in Spain.
Trial summary
The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Adenocarcinoma of the Pancreas, Pancreatic Cancer
- What is being tested?
- HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 Dec 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors, the tumors must be located only in the liver and/or lung, and the metastatic tumors must be stable.
- Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.
- Subject can tolerate general anesthesia.
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- Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-1 at baseline.
- Subject meets the following criteria ≤14 days prior to the planned index procedure date:
- Hemoglobin ≥ 9 g/dL,
- Neutrophil count >1.0 x 10^9/L,
- Platelet >50 x 10^9/L,
- Total bilirubin ≤2.5x Institutional Upper Limit of Normal (IULN),
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5x IULN,
- International Normalized Ratio (INR) value <1.5,
- Serum creatinine <2.0mg/dL or an estimated glomerular filtration rate (eGFR) ≥45mL/min.
- The targeted pancreatic tumor is ≥2 cm in longest diameter.
- The planned histotripsy treatment volume is ≥1.0 cm from any portion of the duodenum, small intestine, stomach, or colon as visualized on ultrasound, and CT, or MR imaging.
- Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.
- Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors are present in the pancreas.
Who cannot join
- 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.
- Subject has a life expectancy of less than six (6) months.
- Subject has a biliary or pancreatic stent and/or percutaneous biliary tube that encompasses the planned histotripsy treatment volume.
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- Subject has metastases to organs other than the liver and/or lung (e.g., bone, brain, peritoneum).
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- Subject has an active duodenal or gastric ulcer requiring medical management.
- Subject is undergoing active chemotherapy for any cancer ≤7 days prior to planned index procedure date.*
- Subject is undergoing active immunotherapy or targeted therapies ≤30 days prior to planned index procedure date.
- Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation).
- Subject has a planned cancer treatment (e.g., pancreatic surgery, targeted therapy, immunotherapy) exclusive of chemotherapy, ≤30 days post index procedure.
- Subject has planned chemotherapy ≤14 days post index procedure.*
- Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency).
- In the investigator's opinion, histotripsy is not a treatment option for the subject.
- Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
- Subject's tumor is not treatable by the System's working ranges (refer to User Guide).
- () Subject must not be off chemotherapy >21 days in total.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Santiago Sanchez Cabús, SSanchezCa@santpau.cat
María Español Vicente, MEspanolV@santpau.cat
About this study
The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
Read the 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.
- Being tested
- HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsyDevice
Histotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.
| Study group | Role | What they receive |
|---|---|---|
| HistoSonics System | Experimental | Not described Receives: Device: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 30 days post histotripsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start10 Dec 2024
- Primary completionMar 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multi-center, single-arm, feasibility trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HistoSonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282809
- Sponsor's protocol ID
- CSP3325
- Acronym
- GANNON
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
- ClinicalTrials.gov ID
- NCT06282809
- Acronym / sponsor ID
- GANNON / CSP3325
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multi-center, single-arm, feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| HistoSonics System | Experimental | Device: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors, the tumors must be located only in the liver and/or lung, and the metastatic tumors must be stable.
- Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.
Key exclusion criteria (19 listed)
- 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.
- Subject has a life expectancy of less than six (6) months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsyHistotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue. | Device | HistoSonics System |
Primary outcome
Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy
Time frame: 30 days post histotripsy procedure
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy in people with Pancreas Cancer and Adenocarcinoma of the Pancreas, run by HistoSonics, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Secord (612-351-0361, zoe.secord@histosonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy (time frame: 30 days post histotripsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.