neoSurgical Inc. has begun a postmarket surveillance study of its FDA-cleared device, neoClose, at University of Texas Health Sciences Center at Houston. The randomized study will compare neoClose against the standard of care for closure in a bariatric surgery gastric bypass population of 70 adults aged 18-70 years with BMI greater than 35.
Principal investigators include: Erik B. Wilson, M.D., professor of surgery; Peter A. Walker, M.D., assistant professor of surgery; and, Shinil K. Shah, DO, assistant professor of surgery.

“Surgeons in hospitals across the United States are rapidly adopting our neoClose device. This postmarket surveillance study is intended to build our clinical evidence behind neoClose and to begin to establish the superiority of neoClose versus the standard of care for closing port sites – a standard that absolutely must be improved to enhance patient outcomes and safety,” said Barry Russell, CEO of neoSurgical. •