ReShape Medical, a weight loss company based in San Clemente, California, announced that it had closed enrollment for a clinical trial of its intragastric balloon, dubbed the ReShape Duo. The ReShape Duo is a weight loss system that does not require surgery.
According to a press release by the company, intragastric balloons are designed to give patients a sense of fullness that helps promote reduced food intake. The devices are inserted by a physician into a patient’s stomach with an endoscope. Once inserted, the balloons are inflated with a specialized saline solution. Since the saline-filled balloons reduce the free volume of a patient’s stomach, the devices provide “built-in portion control.”
The devices are designed to remain in the stomach for six months. After this time, the balloons are drained with a specialized endoscope and removed through a patient’s mouth.
The REDUCE trial by ReShape was able to enroll 326 qualified participants in less than 24 weeks. Since patient enthusiasm for the device was high, the trial reached its capacity earlier than expected.
Dr. Jaime Ponce was the principal investigator for the study. In prepared remarks, he said, "This is the 1st non-surgical weight loss device to be studied since the FDA announced their risk stratified approach to weight loss products." He continued, "We're very enthusiastic about its potential to help patients lose significant weight, without surgery."