neoSurgical Inc. has begun a postmarket surveillance study of its U.S. Food and Drug Administration-cleared device, neoClose, at the University of Texas Health Sciences Center in 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 a Body Mass Index of more 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, D.O., 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.

Laparoscopic abdominal surgery requires small incisions or “port sites” in the abdomen. The port site must be closed after lap surgery. While lap surgery itself is minimally invasive, “herniation,” or protrusion of abdominal tissue through the port site after closure (commonly referred to as “trocar site hernia,” or “TSH,” among doctors), can lead to morbidity due to small bowel strangulation, for example, or nerve and vessel entrapment, resulting in infection, bleeding and pain.

Until 2014, TSH complications were thought to occur at a reported rate of about 1 percent to 6 percent among the 6 million lap surgery port sites closed each year. But in a groundbreaking clinical study nearly 26 percent of patients were diagnosed with TSHs. Thus, TSHs have been grossly under-diagnosed.

In a second published study the total trocar site hernia rate was 39.3 percent at three years.

Most recently a third, multi-institutional study revealed that hernia occurrence can lead to a repetitive cycle of repeat procedures and complications. The standard for port site closure has been Closed Loop Suture. But neoClose works through the use of a Vector X closure, approximating the tissue together and tying into place for a secure closure with up to 75 percent less tension compared to standard closed loop suture, according to clinical evidence.

neoSurgical is a commercial-stage company that develops surgical products. The company’s initial device, neoClose, is approved for sale in the United States and Europe and designed to be the new standard for lap surgery port site closure, a potential $300 million opportunity. The company’s neoClose system for port site closure after laparoscopic surgery has now been used more than 7,000 times in hospitals across America.

Watch the video below to learn more about the neoClose device: