Colovac is designed as an alternative to the temporary bypass stoma for patients undergoing colorectal resection. Up to 20 US and European sites will enroll patients in the study. A revolutionary endoluminal bypass sheath, Colovac was developed by SafeHeal™, a leading innovator in the field of digestive surgery.
Currently, patients undergoing colorectal resection receive a stoma to create an opening from inside the body to the outside, providing a new way for waste to leave the body in a pouch carried by the patient.
“We are thrilled to be the first investigational site in the United States to enroll patients in SafeHeal’s clinical trial of the Colovac device,” Marcet said. “Treatment of rectal cancer most often involves radiation therapy and chemotherapy followed by surgical removal of the rectum. Since the risk of the bowel anastomosis not healing is high and the consequences can be disastrous, The surgeon temporarily diverts stool from the anastomosis into a stoma.The patient retains the stoma for approximately 2-6 months, and the eventual reversal of the stoma requires another operation, hospitalization, and recovery period. The purpose of the SafeHeal study is to see if these patients can safely avoid a stoma and avoid additional operations.Our initial experience with this device has been positive and we are excited to be able to offer this advanced technology to our patients as part of of the study.
The highest ranked hospital in the market in US News & World Report’s Best Hospitals 2021-22, and one of the top four hospitals in FloridaTampa General is one of the highest rated hospitals in Florida for gastroenterology and gastrointestinal surgery. The University Medical Center is #26 in the country and #1 in Florida. “We are steadfastly focused on providing the safest and most innovative care for colorectal cancer patients, which is why we are always eager to participate in clinical trials,” Marcet noted.
An anastomosis is a surgical connection between two structures. When part of a bowel is surgically removed, the two remaining ends are sewn or stapled together (anastomosed). The procedure is known as bowel anastomosis.
The SAFE-2 randomized controlled IDE study will evaluate the safety and effectiveness of the Colovac Intraluminal Bypass Sheath (in the gut) in adult patients who were initially scheduled to receive a bypass stoma after colorectal surgery. Bypass stoma, the current standard of care, is applied prophylactically to most patients today undergoing low anterior resection (LAR) and anastomosis, due to the high risk of anastomotic leak in this cohort of patients. Anastomotic leak, or incomplete healing of the anastomosis, occurs in up to 20% of patients undergoing LAR. It is considered one of the most serious complications of colorectal surgery, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and potential mortality.
“Participating in a study of this caliber for a potentially revolutionary advance in colorectal surgery patient care aligns with our vision to be the safest and most innovative academic healthcare system in America,” said Dr. . Abraham Schwarzbergchief of oncology and senior vice president of network development, Tampa General.
Each year, approximately 500,000 patients worldwide undergo low anterior resection surgery, defining the broad opportunity for the Colovac device to dramatically improve patient outcomes and recovery.
“The initiation of our SAFE-2 study represents the achievement of a critical milestone on our path to eventual market approval by the FDA and has a positive impact on the care and quality of life of colorectal surgery patients,” said the CEO of SafeHeal. Karl Blohm.
ON TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1,041-bed nonprofit academic medical center, is one of America’s largest hospitals and provides world-class care as the region’s only trauma center. level I and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report’s 2021-22 Best Hospitals, and one of the top four hospitals in Floridawith five specialties ranked among the best programs in United States. The University Medical Center’s commitment to growing and developing its team members is recognized by two prestigious 2021 Forbes magazine rankings – America’s Top Employers by State, Third out of Florida’s 100 Companies and First Among Healthcare Organizations. health and social and 13and nationally in America’s Best Employers for Women. Tampa General is the safety net hospital for the region, caring for everyone regardless of ability to pay, and in fiscal year 2020 provided net community benefit worth more than $182.5 million in the form of health care for underinsured patients, community education and financial support to community health organizations in Tampa Bay. It is one of the nation’s busiest adult solid organ transplant centers and the primary teaching hospital for 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 is home to a nationally accredited comprehensive stroke center, and its 32-bed neuroscience and critical care unit is the largest on the west coast of Florida. It also houses the 82-bed Jennifer Leigh Muma 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 network of clinics powered by Fast Track, 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 nation, Tampa General Hospital is the 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 lower cost. For more information, visit www.tgh.org.
ABOUT USF HEALTH
USF Health’s mission is to imagine and implement the future of healthcare. It is the partnership of USF Health Morsani College of Medicine, College of Nursing, College of Public Health, Taneja College of Pharmacy, School of Physical Therapy and Rehabilitation Sciences, Curriculum graduate and postdoctoral fellowships in biomedical sciences and USF Health. group of multi-specialist physicians. the University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the nation has moved up the US News & World Report National University Rankings faster than USF. For more information, visit health.usf.edu.
ABOUT SAFE HEAL
SafeHeal SAS, headquartered in Paris, Franceand its wholly-owned U.S. subsidiary, SafeHeal Inc., is a clinical-stage medical device company developing Colovac, a device invented by French digestive surgeon Dr. Sharam Khosrovani, to avoid the need for a digestive stoma in patients undergoing colorectal surgery. Colovac is a flexible shunt sheath intended to reduce the contact of feces at the anastomotic site following colorectal surgery. The device is placed endoluminally and is fully reversible. The device stays in place for 10 days, until the body’s natural tissue healing and repair processes are complete, after which it is removed in an endoscopic procedure without the need for a second surgery . This allows patients to return to normal life without the stigma and complications associated with an ostomy procedure. Colovac is an investigational device, currently not available for sale.
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SOURCE Tampa General Hospital