Pancreatic Cancer Trial, Recruiting NCT06282809 Sponsor: HistoSonics, Inc. Condition: Pancreatic Cancer
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Pancreatic Cancer Trial, Recruiting

NCT06282809
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older.
  • People who are willing to sign a consent form approved by an Ethics Committee before any trial-related tests or procedures, and who are willing to follow the trial steps and attend required follow-up visits.
  • People who have been diagnosed with pancreatic cancer that cannot be removed by surgery — either locally advanced (Stage 3) or with a small number of spread sites (Stage 4) — confirmed by a CT or MRI scan taken within 14 days before the planned procedure. If Stage 4, there must be no more than 5 tumors that have spread, those tumors must be in the liver and/or lungs only, and they must be stable.
  • People who are not suitable for surgery and who have already received chemotherapy for at least 8 weeks.
  • People who are able to safely receive general anesthesia.
  • People who have a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work), as assessed at the start of the trial.
  • People whose blood test results, taken within 14 days before the planned procedure, meet specific minimum standards for blood cell counts, liver function, kidney function, and blood clotting (confirm with trial site for exact values).
  • People whose main pancreatic tumor measures at least 2 cm at its widest point.
  • People whose tumor is located at least 1 cm away from nearby digestive organs such as the small intestine, stomach, or colon, as seen on medical imaging.
  • People whose tumor can be clearly seen using the ultrasound equipment used in this trial.
  • People who will have only one pancreatic tumor treated during the procedure, even if more tumors are present in the pancreas.

Who may not be able to join:

  • People who are pregnant, planning to become pregnant, or currently breastfeeding during the trial period.
  • People who have previously had surgery on the pancreas, the bile system connecting to the intestine, or the stomach.
  • People who are currently taking part in another clinical trial of a drug or medical device that has not yet completed its main study goals, or that could affect this trial's results.
  • People who have a blood clotting problem that cannot be corrected.
  • People whose life expectancy is less than six months.
  • People who have a stent or drainage tube in the bile duct or pancreas that overlaps with the area planned for treatment.
  • People whose cancer has spread to organs other than the liver or lungs (for example, to the bones, brain, or the lining of the abdomen).
  • People who have a known allergy to contrast dye used in medical imaging and for whom pre-treatment medication cannot adequately manage that reaction.
  • People who have an active ulcer in the stomach or the first part of the small intestine (duodenum) that requires medical treatment.
  • People who have received chemotherapy within 7 days before the planned procedure date, noting that overall time off chemotherapy must not exceed 21 days in total.
  • People who have received immunotherapy or targeted cancer therapies within 30 days before the planned procedure.
  • People whose specific tumor being targeted has already been treated with a local therapy such as ablation, embolization, or radiation.
  • People who have a cancer treatment other than chemotherapy (such as pancreatic surgery, targeted therapy, or immunotherapy) planned within 30 days after the procedure.
  • People who have chemotherapy planned within 14 days after the procedure, noting that overall time off chemotherapy must not exceed 21 days in total.
  • People who have not sufficiently recovered from side effects of chemotherapy or immunotherapy (confirm with trial site for specific recovery standards), not including hair loss, nerve-related side effects, or digestive enzyme problems.
  • People for whom the treating investigator considers this procedure not to be an appropriate treatment option.
  • People who have another health condition that could put their safety at risk or affect their ability to follow the trial requirements.
  • People whose tumor cannot be reached or treated within the operating range of the trial's medical device.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 612-351-0361

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
HistoSonics, Inc.
Registry
ClinicalTrials.gov
Start date
10 December 2024
Est. completion
1 March 2028

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov