Gastric balloon devices are now proving to be a promising alternative to more invasive surgical procedures such as lap bands and gastric bypass when it comes to helping obese patients lose substantial amounts of weight after repeated failures with exercise and diet programs alone. And while the “Reshape Dual Balloon” system approved by the Food and Drug Administration does require endoscopic surgery performed under mild sedation to insert it into the stomach, Allurion Technologies’s Ellipse System is even far less invasive. According to the company, delievery of the Ellipse System into the body merely requires patients to swallow a single capsule attached to a small catheter which leads back up to the mouth. Once the capsule reaches the stomach, it dissolves releasing a mini deflated gastric balloon, which is then filled with 550 ml of liquid via the catheter until it is the size of a grapefruit. The catheter is then removed and the patient is ready to go home.
The idea is to occupy a large part of the stomach’s available space, so that there is less room for food, creating a feeling of “fullness.” As a result, patients eat less, and learn to control portions better, without having to measure every bite. After 4-months, a valve is said to open automatically, releasing the liquid and allowing the deflated balloon to pass through the bowels as regular waste.
Although Ellipse has yet to be green-lighted for sale by the FDA, clinical trials involving 34 patients in the Czech Republic and Greece have shown that participating patients lost an average of 22 pounds during the 4 months it was inside their stomachs (or about 33%) of their body weight. In addition, researchers noted that the device helped to lower the patients’ hemoglobin A1c and triglyceride levels reducing their risk for diabetes and coronary disease. In addition, study leaders noted that the participants were able to keep off about half the weight loss after 1 year, although the number decreased to about 30% of the weight after 5-years.
Typical side effects (as with other gastric balloons) included nausea and vomiting, Still, the system seems to be safe, and it is believed that its “non-invasive” approach may make it more appealing to people reluctant to have any kind of alterations made to their internal plumbing. It should be noted, however, that these types of procedures are not meant to be used in patients whose body mass index (BMI) is less than 35.