Tampa General is one of the first sites in the nation to study the safety and efficacy of the device, which aims to use focused ultrasound to destroy tumors in the liver.
Tampa, FL (Jan. 20, 2021) – Tampa General Hospital is one of the first sites in the nation to study whether a new technology can safely and effectively destroy tumors without using an invasive procedure.
The new technology, called histotripsy, aims to mechanically destroy tumors using focused ultrasound. Tampa General recently became the first U.S. trial site to have its institutional review board approve the trial, which means that the hospital could be the first U.S. location to enroll a patient in the trial.
The #HOPE4LIVER trial will enroll patients who have liver tumors that are considered inoperable. The histotripsy technology is in the investigative stages and does not yet have FDA approval. The trial is an important step in seeking that approval.
“Tampa General is pioneering new ways to save lives by testing innovative solutions to the most difficult medical problems,” said Tampa General President and CEO John Couris. “As an academic medical center, discovering new treatments through this kind of groundbreaking research is a vital part of our mission to deliver world-class care to our patients.”
The technology which delivers the histotripsy treatment, developed in partnership with the University of Michigan, will be administered at Tampa General through a novel device called the HistoSonics System. The HistoSonics System harnesses a phenomenon in ultrasound that was originally believed to be a problem: Ultrasound waves can create bubbles of gas within individual cells. Scientists originally believed these bubbles could not be controlled and should be avoided.
But in histotripsy, scientists intend to use focused ultrasound to create pulsed sound waves in targeted tissue, such as a tumor. The sound waves create microscopic bubbles within the cells, which cause the cells to rupture and die. What’s left behind should be just acellular debris that is gradually absorbed and disposed of by the body’s normal processes.
“There are no probes, scalpels or invasive procedure,” said Dr. Cliff Davis, assistant professor and director of the Interventional Radiology Residency Program in the USF Health Morsani College of Medicine, and principal investigator of the #HOPE4LIVER trial at the TGH site. “There is a treatment arm with an ultrasound on it. We visualize the tumor and the HistoSonics System delivers the ultrasound wave energy to the cells…there is no heat, no cold, no electrical current.”
These treatments have the potential to spare the body’s critical collagen structures, such as blood vessels and ducts. If the trial is a success, Davis said, histotripsy has the potential to eventually treat tumors in other parts of the body.
The trial is being conducted at Tampa General with both private practice physicians on the TGH medical staff and faculty members at the USF Health Morsani College of Medicine.
HistoSonics President and CEO Mike Blue is excited to see Tampa General moving ahead as the first site with IRB approval for the trial.
“The approval of this study represents a significant milestone to our company and is the culmination of a tremendous amount of work and dedication by a great number of people whose life-work has been the development of histotripsy,” he said. “As the next step, I am incredibly excited to partner with Tampa General Hospital and their multi-disciplinary liver team as an enrolling site in the #HOPE4LIVER trial.”
The HistoSonics System is not yet commercially available and is for investigational use only. Final performance specifications and claims are subject to change pending the completion of regulatory market-access activities. HistoSonics sees wide potential use for this technology but the first application for which the company will seek FDA approval is for the destruction of targeted liver tissue.
ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1006-bed non-profit academic medical center, is one of the largest hospitals in America and delivers world-class care as the region’s only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report’s 2020-21 Best Hospitals, and one of the top 4 hospitals in Florida, with five specialties ranking among the best programs in the United States. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center and its 32-bed Neuroscience Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital’s footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health and 19 outpatient Radiology Centers. Tampa Bay residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in the country, Tampa General Hospital is first in Florida to partner with GE Healthcare and open a clinical command center that uses artificial intelligence and predictive analytics to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.