Allurion Technologies has completed patient enrolment in its AUDACITY trial, a randomised, pivotal controlled trial designed to support FDA approval of the Allurion Balloon. The trial enrolled 550 patients at 17 sites and completed enrolment two months ahead of schedule.
The Allurion Balloon is the world’s first and only swallowable, procedure-less gastric balloon for weight loss and was designed to address various shortcomings of legacy gastric balloons. It is swallowed as a capsule and filled under the guidance of a health care provider without surgery, endoscopy, or anaesthesia. The placement takes approximately 15 minutes during an outpatient visit. Approximately four months later, a patented ReleaseValve opens, allowing the balloon to empty and pass out of the body naturally. The patient does not need to return to the doctor to have the balloon removed.
“I believe the brisk enrolment in the AUDACITY trial reflects the broad appeal of a novel, completely reversible weight loss device,” said Dr Shelby Sullivan, Director of the Gastroenterology Metabolic and Bariatric Program at the University of Colorado School of Medicine and Principal Investigator of the AUDACITY trial. “As the obesity epidemic worsens in the US, I expect options like the Allurion Balloon will be attractive to a large segment of the population.”
The AUDACITY trial website received 78,106 unique visitors of whom over half or 39,947 completed a pre-screen questionnaire.
“We were pleased to see such a high level of interest in the Allurion Balloon in the United States,” said Jay Donosky, Vice President of Clinical Affairs for Allurion. “As interest in weight loss grows in the United States with the rise of GLP-1 drug therapy, we believe our robust enrolment is indicative of a strong desire for alternative first-line options.”