A Natick weight loss device company has begun a clinical trial in the U.S. with the hopes of soon gaining U.S. Food and Drug Administration approval.
Allurion Technologies, makers of a gastric balloon for weight loss, launched the trial in February and completed enrollment in the trial and more than 400 patients have been enrolled.
The device, the Elipse Balloon, is swallowed in a capsule and filled with liquid through a thin catheter, which is then detached. The device remains in the stomach for about four months, after which it opens and the matter is passed naturally from the body.
A study outside of the U.S. found overweight and obese patients lost an average of 29 to 33 pounds from using the device. The U.S. trial, taking place in 11 centers throughout the country, is expected to yield results in May 2019.
The device is marketed for its ease of use and brief outpatient doctor visit to have it inserted.
“The remarkable demand we observed during enrollment supports the consumer-facing approach we took in the design of the Elipse Balloon,” said Ram Chuttani, the company’s chief medical officer, in a statement. “With enrollment behind us, we are looking forward to receiving top-line results early next year.”
