Apr 22, 2015 By David Singer 3 min read

Allegheny Health Network is one of 15 health centers participating in the first U.S. clinical trial of the Obalon Balloon, a device swallowed by patients and inflated to curb appetite and combat obesity. The device has already been approved for use in Europe since 2014, and company representatives said their trials there showed up to 50 percent in reduction of excess body weight and a 2.8 reduction in a person’s body mass index, or BMI.

“These balloons are aimed as a treatment for those with a BMI between 30-35, really the gap group … because surgical intervention is often required for those above 35, but not recommended for those below it; there’s really a lapse in available treatments in the U.S. for this group of patients who don’t need gastric bypass or other invasive measures,” said Dr. George Eid, head trial researcher and director of Allegheny Health Network’s Bariatric and Metabolic Institute.

That’s balloons, plural, as Dr. Eid said the trial has about 20 local patients swallowing the first Obalon “pill,” which is inflated via an oral catheter; the patients then return in later weeks to swallow and inflate a second and third balloon to maximize the fullness that the stomach will feel to help curb hunger and manage portion control. Each balloon weighs about 6 grams and inflates to 250cc.

“Dietary counseling is a big compliment to this and is included in the trial. It’s modifying behavior … it’s not a cure for obesity, or for the conditions closely correlated with obesity, like diabetes and heart disease,” Dr. Eid said.

The balloons, made of multi-composite plastics and rubbers, can stay in the stomach for six months-around the time of the end of the trial.

“Once we confirm the balloons are safely in the stomach with X-ray scans, we monitor the patients … and extract the balloons at the end of the trial. The date will be handed off to the Food and Drug Administration for approval in 2016,” he said.

The balloons are removed through sedated endoscopic surgery, or, in other words, pulling them out through a patient’s mouth.

The European Medicines Agency (EMA), the cross-continent equivalent of the FDA, approves trial treatments more quickly than the U.S. agency because “they’re only checking for safety, not efficacy. They kind of let the markets sort it out there, while the FDA measures whether it’s effective, which takes longer,” said Dr. Eid.