Investigator-sponsored Research (ISR) Program

HistoSonics is committed to supporting investigator-sponsored clinical studies involving the Edison System that are designed to provide valuable scientific and clinical information leading to improved clinical care.
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Two professionals review scans together
HistoSonics is interested in supporting clinical studies of histotripsy in the liver which investigate the following areas of research interest:
  • Tumor subtypes (e.g., hepatocellular carcinoma, colorectal liver metastasis, cholangiocarcinoma, neuroendocrine, hepatic adenoma, hilar, other liver metastases)
  • Technical and procedural aspects (e.g., number of treatments, treatment volume, liver condition, advanced imaging, type of anesthesia)
  • Combined or prior therapy (e.g.,post-radiation recurrence, concurrent immunotherapy/chemotherapy, presurgical therapy, bridge to transplant)
  • Local effects (e.g., tumor microenvironment, blood flow, hypoxia, immunology)

Submission & Review Process

To request financial study support from HistoSonics, investigators must submit a study concept  by completing a Study Concept Proposal Form. If HistoSonics determines the study concept is of interest, the investigator will be invited to submit a full study proposal. Please note that HistoSonics does not contemplate providing product or systems as part of our support for ISR studies at this time and can only support studies conducted in a country where the Edison System has regulatory authorization, which is currently limited to the United States.

A full study proposal is required for funding approval and includes:

  1. A draft protocol containing the background, study objective(s), study design, inclusion/exclusion criteria, treatment details, follow-up visit schedule, and statistical method.
  2. An itemized budget outlining specific items for which support is sought.  The budget may include, but is not limited to, research activity-related personnel costs (e.g., research assistant, statistician, medical writer), data management expenses, and IRB review fees.
  3. Sponsor organization’s W-9 form.

Complete proposals will be reviewed and assessed by the ISR Committee based on scientific merit, strategic fit, the investigator’s qualifications, histotripsy experience, research experience, and requested monetary support. There is no guarantee of funding. Funding will be provided only with a fully approved grant agreement.

The investigator is responsible for complying with all applicable laws and regulations regarding human clinical studies.  The Edison System’s indications for use are for the destruction of liver tumors, including unresectable liver tumors, using a non‑thermal, mechanical process of focused ultrasound. Note that all human clinical studies in the US must be evaluated against 21CFR Part 812 to determine if an FDA Investigational Device Exemption is required.

SUBMIT AN ISR CONCEPT PROPOSAL

Please send completed proposal form to ISRProgram@histosonics.com

Download Form

QUESTIONS

Please contact us if you have any questions regarding the Investigator-Sponsored Research Program.

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Last updated on January 3, 2024

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.

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