Orlando Health has taken a lead position as the first site in the nation to enroll patients in a pivotal clinical study using electroporation therapy in the disease management of diabetes. Manoel Galvao Neto, MD, director of bariatric research, and Andre Teixeira, MD, director of Orlando Health Weight Loss and Bariatric Surgery Institute, are overseeing the study.
The multicenter, double-blinded, sham-controlled study will assess the safety and effectiveness of the ReCET System by Endogenex, enrolling up to 350 patients. The system has received FDA Breakthrough Device Designation for treating adults with type 2 diabetes poorly controlled by glucose-lowering medications. Orlando Health joins Johns Hopkins University, Mayo Clinic and 19 other leading U.S. and Australian institutions in the study.
Dr. Galvao, the co-creator of bariatric endoscopy, is internationally recognized for his participation in several groundbreaking clinical trials, including a recent U.S. trial using endoscopic suturing, which he helped develop.
“This is a complex FDA study with 17 inclusion criteria, 51 exclusion criteria and follow-up for at least 2 years,” says Dr. Galvao, who joined Orlando Health in January 2024. “While we are a community hospital, we have a mature research division capable of delivering the high standard of care necessary for very, very complex clinical studies like this.”
The endoscopic outpatient procedure focuses on duodenal mucosal resurfacing, targeting and disrupting the cellular pathology of the duodenum for better glucose control. During the one-hour procedure, a small coil positioned by catheter applies a precisely controlled, pulsed electric current to the mucosal and sub-mucosal lining of the duodenum to induce a natural cellular death and initiate cellular regeneration.
“Peeling back the surface of epithelium to the mesenchymal cells and ablating them triggers the body’s natural process to regenerate healthy cells that are less metabolic and diabetic,” says Dr. Galvao, a noted pioneer in duodenal mucosal resurfacing research. “The intent of the procedure is to slow the progression of type 2 diabetes and improve blood sugar control, while reducing dependence on medication.”
Orlando Health is accepting patients from regional colleagues who can refer by calling study coordinator Leticia Morales at (321) 841-9623 or through Endogenex centers.
Orlando Health is dedicated to revolutionizing patient care with outcomes advanced by specialists skilled in the most leading-edge technologies and involved in advanced clinical research and training. Board-certified surgeons with Orlando Health Weight Loss and Bariatric Surgery Institute specialize in complex minimally invasive procedures, both endoscopically and robotically, to advance patient care. The program is accredited as a Comprehensive Center under the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP®).
Complex Abdominal Surgeries Are ‘a Very Common Scenario Here’
