BaroNova said today it enrolled the 1st 4 patients in its ENDObesity II study pivotal clinical trial to test its TransPyloric Shuttle designed to treat obesity.
The TransPyloric Shuttle is inserted and removed through the mouth endoscopically to slow gastric emptying and encourage weight loss, the company said. In a feasibility study, patients with BMIs of 30-40 kg/m2 reported average excess weight loss of 58% after 6 months.
“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,” lead investigator Dr. Richard Rothstein of Hanover, N.H.’s Geisel School of Medicine at Dartmouth said in a prepared statement.
The 12-month, multicenter pivotal clinical trial is slated enroll 270 patients at up to 12 sites in the U.S.
“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,” CEO Hugh Narciso said in a press release.
Goleta, Calif.-based BaroNova said it hopes to use results from the trial to support an FDA application for regulatory approval and future commercialization of the device.
“With over 35% of adults and 17% of children classified as obese in the United States, we are committed to bringing this innovative technology to patients in need,” clinical affairs veep Dr. Lian Cunningham said in prepared remarks.
“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 12 months,” Dr. Shelby Sullivan of St. Louis, Mo.’s Washington University School of Medicine said in a press release.