BAROnova announced the enrollment of the first four patients in its ENDObesity® II Study, a twelve-month multicenter pivotal clinical trial designed to test the safety and effectiveness of the TransPyloric Shuttle® (TPS®) to treat obesity.
Richard Rothstein, MD, the lead investigator of the study and the Joseph M. Huber Professor and Chair of the Department of Medicine at the Geisel School of Medicine at Dartmouth in Hanover, NH, said, "This study will contribute significantly to the understanding of endoscopic therapies for the management of obesity, which has continued to rise as a major health challenge. Our patients need alternatives to invasive bariatric surgical procedures. The TPS showed great promise in its initial feasibility study and we are enthusiastic to begin the pivotal trial at this time."
Shelby Sullivan, MD, Assistant Professor of Medicine and Director of Bariatric Endoscopy at Washington University School of Medicine in St. Louis, MO, stated, "We successfully enrolled and did procedures on the first four participants in the ENDObesity II Study. We are looking forward to enrolling more participants at our site and ultimately evaluating the effects of the TransPyloric Shuttle at twelve months."
"Initiation of this pivotal trial is an important milestone for the company and is the first step on the path to provide a less-invasive, removable, low-cost medical device to combat obesity," said Hugh Narciso, Founder, President and CEO of BAROnova. Lian Cunningham, MD, PhD, Vice President of Clinical Affairs at BAROnova, added, "With over 35 percent of adults and 17 percent of children classified as obese in the United States, we are committed to bringing this innovative technology to patients in need."
The ENDObesity II Study is projected to enroll 270 patients at up to 12 sites in the United States. The results from this study are expected to support an FDA application for TPS approval and subsequent domestic commercialization of the device.