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Safety, efficacy trial begins for endoscopic weight-loss device

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The first four patients have been enrolled in the ENDObesity II study designed to evaluate the safety and efficacy of the TransPyloric Shuttle, according to a press release from BAROnova Inc.

The TransPyloric Shuttle is a removable weight-loss device that is inserted endoscopically through the mouth. In a previous feasibility study, the TransPyloric Shuttle demonstrated a 58% weight loss after 6 months in patients with a BMI of 30 to 40 kg/m².

“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,” Richard Rothstein, MD, chair of the department of medicine at the Geisel School of Medicine at Dartmouth, said in the release. “Our patients need alternatives to invasive bariatric surgical procedures. The [TransPyloric Shuttle] showed great promise in its initial feasibility study, and we are enthusiastic to begin the pivotal trial at this time.”

The study is projected to enroll at least 270 patients over 12 sites in the United States.

“We successfully enrolled and did procedures on the first four participants in the ENDObesity II Study,” Shelby Sullivan, MD, assistant professor of medicine and director of bariatric endoscopy at Washington University School of Medicine in St. Louis, Missouri, said in a press release. “We are looking forward to enrolling more participants at our site and ultimately evaluating the effects of the TransPyloric Shuttle at 12 months.”