San Clemente, Calif.-based ReShape Medical closed pivotal trial enrollment for its ReShape Duo non-surgical weight-loss system, the company announced this week.
ReShape’s Duo system is comprised of dual intra-gastric balloons that are placed in the stomach non-surgically via an endoscope inserted into the mouth. The balloons takes up space in the stomach to help patients feel full faster, causing them to eat smaller portions.
The Duo device aims to help patients lose weight as well as change eating habits, a company spokesperson told MassDevice.com in an email.
ReShape’s REDUCE trial enrolled 326 subjects in fewer than 6 months, a testament to the high level of patient enthusiasm for a new generation of weight-loss devices, according to the company.
"There is tremendous patient interest in a non-surgical approach to weight loss," study investigator Dr. George Woodman said in prepared remarks. "We had many more potential subjects than we could actually enroll."
As of an interim analysis of patient outcomes, an independent statistician determined that there was no need to increase enrollment, although more patients were eager to sign up.
"We can now complete the study on time and with greater confidence in a positive outcome," ReShape Medical clinical, regulatory & quality vice president Mary Lou Mooney said in prepared remarks.
The ReShape Duo represents a departure from traditional weight-reducing medical devices, the company noted. The deflated balloons are inserted without the need for sutures or incisions. They are fed into the stomach where they’re filled with saline, occupying space in the stomach to serve as "built-in portion control," according to a company video.
The balloons remain in the stomach for a period of 6 months, after which they are drained via endoscope and removed through the mouth.
The ReShape Duo system has been on the market in the European Union since December 2011, but are limited to investigational use in the U.S.
"This is the 1st non-surgical weight loss device to be studied since the FDA announced their risk stratified approach to weight loss products," principal investigator Dr. Jaime Ponce said in prepared remarks. "We’re very enthusiastic about its potential to help patients lose significant weight, without surgery."